Risk Based Joint Inspection Format

Risk Based Joint Inspection Report
Page 1 of 64
As per the said direction, the SOP and
checklist benchmarking tool available at
CDSCO website under public notice
vide F.No. DCGI/Misc/2016(60) dated
26/05/2016 is used for the inspection
purpose. The details are reported
hereunder:Name of the
Manufacturing Unit
Address
Mfg. Lic. No.
Validity of License
Constitution of the firm

List of Directors/ Partners/
Proprietor
License Issuing Authority
Categories of drugs permitted to be
manufactured
Specify whether COPP has been
issued to the firm
Name and Designation of the
Inspecting team members
Site Specific Data
No. of Products manufactured at site
(during last year)
No. of manufacturing blocks
No. of Technical Personnel in

Manufacturing
No. of Technical Personnel in QA
No. of Technical Personnel in QC
Page 2 of 64
No. of Technical Personnel in
Microbiology
No. of Technical Personnel from

another Department
No. of Technical Personnel in R&D
No. of technical personnel in

Formulation development
No. of Samples drawn by QC (during

last year)
No. of Samples declared OOS

(during last year)
No. of samples declared NSQ by

Govt. Analyst (during last five year).
Collect reasons for such failures and
annexe with this checklist
Observations should be descriptive without ambiguity and answer like "Yes" or "No"
should be avoided
Page 3 of 64
Ratin
1 Building and premises: - Observations
g
Specify whether the whole facility
is separated, dedicated and is not
1.1 Sch-M
a part of any other non-drug
facility.
Specify whether the surroundings
of the manufacturing area is clean
1.2 Sch-M and as per the SOP prescribed in
this regard. (Mention the SOP
nos.)
Describe the pest, insects, birds
and rodents control system
followed in the premises. Specify
1.3 Sch-M
pest control schedule- area wise,
along with materials and methods
used.
What measures have been taken
to make Interior surface (of walls,
floors, and ceilings) smooth and
free from cracks, and to permit
easy cleaning Specify material of
construction and finish for walls,
ceiling, floor, coving etc. i.e.
1.4 Sch-M
whether Epoxy or PU coated, kota
/ granite stone with epoxy sealed
joints, solid / GI / gypsum / cal.
Silicate board ceiling with epoxy,
PU or any other pre-fabricated
panel (GRP, powder coated SS or
Aluminium etc.) paint.
Specify the lux level maintained in
various parts of the premise
(Storage area, manufacturing area
1.5 Sch-M, specially visual inspection,
Laboratory areas etc.).
Specify the air handling system

1.6 Sch-M, used in various areas i.e. stores,
production, packing, QC areas.
Specify drainage system which
prevents back flow and entry of
1.7 Sch-M, insects and rodents into the
premises. Specify number and
location of drains installed.
2
Page 4 of 64
Specify the position of rest and
refreshment rooms and mention
whether they are separated and
2.1 Sch-M,
not leading directly to the
manufacturing and warehouse
areas.
Are there general change rooms in
plant? specify number of washing
2.2 Sch-M,
station & toilets provided for
number of users.
Specify whether primary clean
garments are provided for each
2.3 Sch-M,
personnel entering the factory
premises.
Is there in-house general laundry
for garment washing / cleaning? If
2.4 Sch-M,
not, how garment washing is
carried out and monitored.
Sch-M, Whether change room facilities
2.5
Para separated for both sexes.
Whether maintenance workshop is
Sch-M,
2.6 separated and away from
Para
production.
3
Is the men & material movement
WHO inside the factory premises,
3.1
TRS observed & checked through
security system.
Is CCTV available to control the
WHO
3.2 Entry & Exit from Factory
TRS
premises?
WHO Is there a system for identifying
3.3
TRS persons visiting the factory? How?
What is the precautionary activity
WHO
3.4 taken for the movement of carriers
TRS
i.e., vehicles?
4
Verify whether a current drawing of
Sch-M, the water system showing all
4.1
Para equipment in the system from inlet
to the points of use is available.
Specify the MOC of the water
Sch-M,
4.1.1 storage tank (Both PW & WFI) and
Para
its pipe line.
Sch-M, Specify weather storage tank for
4.1.2
Para WFI is steam jacketed.
Page 5 of 64
Specify whether water system
validation/qualification has been
Sch-M,
4.2 carried out as per protocol and
Para
reports have been prepared and
maintained.
Whether IQ protocol includes at
least facility review, equipment
specification vs. design, welding
roughness testing on pipelines,
IQ protocol did not include at
absence of dead points / section in
least facility review, equipment
the pipelines, pipe and tank
specification vs. design, welding
WHO passivation, drawings, SOP for
4.3 roughness testing on pipelines, 1
TRS-970 operations, cleaning, sanitation,
absence of dead points / section
maintenance and calibration of
in the pipelines, pipe and tank
gadgets. Whether its report
passivation, drawings.
includes Conclusion / Summary,
Data tables, Results, Conclusions,
Protocol reference, Revision and
approval signatures.
The record produced by the firm
showed that OQ protocol did not
Whether OQ protocol includes at
include at least System
least System production capacity
production capacity (L/min), Flow
(L/min), Flow type and water rate,
type and water rate, Valve
Valve operation, Alarm system
operation, Alarm system
WHO operation and Controls operation?
4.4 operation and Controls 0
TRS-970 Whether its report includes
operation? Whether its report
Conclusion / Summary, operations
includes Conclusion / Summary,
performed Data tables, Results,
operations performed Data
Conclusions, Protocol reference,
tables, Results, Conclusions,
Revision and approval signatures.
Protocol reference, Revision and
approval signatures.
Please specify whether Phase 1,
WHO showed that Phase 1, Phase 2
4.5 Phase 2 and Phase 3 studies 2
TRS-970 and Phase 3 studies carried as
carried as part of PQ stages?
part of PQ stages.
Phase 1: Whether the operations
parameters, cleaning and
sanitation procedures & In the protocol the firm has
WHO frequencies defined. Whether incorporated parameters,
4.6 2
TRS-970 daily sampling records for every cleaning, sanitation procedures
pre-treatment point and usage & frequencies defined
point for a period of 2 to 4 weeks
maintained and SOP’s prepared.
Page 6 of 64
In 2nd Phase the firm has
PHASE 2: Whether daily sampling
incorporated daily sampling
records for every pre-treatment
WHO records for every pre-treatment
4.7 point and usage point for a period 2
TRS-970 point and usage point for a period
of 4 to 5 weeks after Phase 1
of 4 to 5 weeks after Phase 1
maintained and reviewed.
maintained and reviewed.
PHASE 3: Whether weekly
Yes, the weekly sampling
WHO sampling records available of
4.8 records available of every usage 2
TRS-970 every usage point for a one-year
point for a one-year period
period.
Specify source of raw water and
give details of treatment
processes, sampling points,
distribution and storage system for
4.9 Sch-M
raw and purified water. Verify
whether the Raw Water holding
tank was sanitized as per specified
SOP.
Verify whether the softener
4.10 Sch-M column is regenerated as per the
specified SOP.
Specify whether the quality of
potable water used for the
preparation of purified water
4.11 Sch-M
meets the requirement of
Schedule M in respect of
microbiological limit.
Specify whether the quality of
Purified Water used for the
4.12 Sch-M
preparation of WFI meets the
requirement of IP/BP/USP.
What is the process for
4.13 Sch-M preparation of Water for Injection
(WFI)?
Specify the process of sanitization
4.14 Sch-M
of SS storage tank of WFI.
Specifywhether the quality of WFI
4.15 Sch-M meets the requirement of
IP/BP/USP & Schedule M.
Specify whether WFI is used for:
1) Bulk preparations of liquid
injections
2) Final rinse of product containers
for sterile preparations.
4.16 Sch-M
3) Final rinse of machine parts (for
sterile preparations)
4) Preparation of disinfectant
solutions for use in critical areas
(for sterile preparations.)
Page 7 of 64
How bio burden in purified water &
WFI are controlled / reduced
4.17 Sch-M
(Mention the SOP no. followed in
this regard).
Specify whether WFI has been
4.17.
Sch-M stored and circulated above 70
1
degree centigrade.
Verify whether the circulation rate
WHO of purified water & WFI is at least
4.18
TRS-970 twice the storage capacity of the
holding vessels per hour.
Verify the Dead leg of non-
WHO
4.19 returned valve at the discharge
TRS-970
point.
WHO Specify how the circulation loop is
4.20
TRS-970 sanitized. Verify the SOP.
Specify whether spray ball is used
WHO
4.21 to wet the surface of head space in
TRS-970
the storage vessel.
Specify whether pressure release
WHO
4.22 valves are provided in the storage
TRS-970
vessel.
How water tanks are cleaned
4.23 Sch-M periodically and records
maintained thereof.
WHO Specify whether on line TOC test
4.24
TRS-970 is available for WFI & PW.
Specify whether replacement of
Air Vent filters on the purified/WFI
PIC/S
water tank is carried out as per
4.25 Guideline
relevant SOP.
s
Whether the provision to keep dry
the vent filter is made.
Specify the arrangement for
4.26 Sch-M preparation of pure steam & its
use.
Specify whether pure steam
(condensate) used in production
meets the microbiological
4.27 Sch-M
specification of not more than 10
cfu/100ml and IP/BP/USP
specifications of WFI.
WHO
4.28 Verify PQ of the PSG.
TRS-970
Specify the system in place for the
4.29 Sch-M compressed gases / air used in the
facility.
Page 8 of 64
Verify the qualification documents
of compressed air system
4.30 ISO/PICS
specially where it comes in contact
with product or primary container.
Specify whether action and alert
WHO limits are followed based on
4.31
TRS-970 qualification of water and
compressed Air system.
5
Specify the system of disposal of
sewage, and effluents (solid,
liquid, and gas) from the
5.1 Sch-M manufacturing site. (Enclosed the
copy of NOC obtained from State
Pollution control board in this
regard.)
Mention the procedure for storage
5.2 Sch-M and disposal of rejected drugs and
applicable SOP.
Whether adequate records are
5.3 Sch-M maintained for the disposal of
waste.
Whether provision for disposal of
bio-medical waste made as per the
5.4 Sch-M provisions of the Bio Medical
Waste (Management and
Handling) Rules 1996.
6
Whether all personnel prior to
employment have undergone
medical examination including eye
examination and are all free from
6.1 Sch-M
Tuberculosis, skin and other
communicable or contagious
diseases & thereafter at regular
intervals.
Whether investigational reports,
e.g. of X rays etc. preserved.
6.2 Sch-M Whether records of such medical
examination are maintained
thereof
Specify whether employees report
their illness to the supervising
6.3 Sch-M
authority before entering into the
production area.
Specify whether person from
6.4 Sch-M infectious disease is barred to
enter into production area.
Page 9 of 64
Specify if any unhygienic practice
6.5 Sch-M is observed within the
manufacturing areas.
Whether all personnel are trained
to ensure high level of personal
6.6 Sch-M
hygiene. Mention the SOP no.
followed in this regard.
Specify whether cross over bench
is in place in the change room and
6.7 Sch-M if so whether it rules out the
possibility of dust particle entering
the clean side.
Whether arrangements provided
6.8 Sch-M for cleaning of outside dust and dirt
from foot.
7
Specify whether basic training on
GMP is provided to all personnel
7.1 Sch-M attached to production and quality
control activity at the time of
induction.
Specify whether specific training
related to the job duty are provided
7.2 Sch-M
to all personnel at the time of
induction.
WHO Specify whether continuous
7.3
TRS-986 training is provided.
Specify whether concept of QA
WHO
7.4 and its importance is part of
TRS-986
training session.
Are all the persons associated with
various production activities
properly trained as per guidelines
provided in WHO working
WHO
7.5 document. Verify the assessment
TRS-986
records of the training of few
selected people who are
associated with critical operations
and procedure
8
WHO Is access to the area restricted to
8.1
TRS-986 authorized personnel only.
Page 10 of 64
Whether adequate areas have
been allocated for warehousing of
Raw Materials, intermediates,
Packaging Material, products in
quarantine, finish products,
8.2 Sch-M
rejected or returned products. How
are these areas marked or
segregated.
Please specify the total area
provided for warehousing.
How the warehousing areas being
maintained to have good storage
8.3 Sch-M conditions. Are they clean and dry
and maintained within specified
temperature limits?
Is there any SOP defining
maximum exposure time at room
WHO
8.4 temperature for thermolabile
TRS-986
materials i.e. prior to storage in a
refrigerator.
Specify the storage arrangement
provided for materials which are
sensitive to temperature, humidity
8.5 Sch-M and light and how the parameters
are monitored.
Is cold room or deep freezers
required for storage of goods?
WHO Verify the Thermal mapping of the
8.6
TRS-986 cold rooms or deep freezers
Whether receiving and dispatch
8.7 Sch-M bays are maintained to protect
incoming and outgoing materials.
How incoming materials are
treated and cleaned before entry
into the plant.
8.8 Sch-M
Please specify the cleaning
system for the outer surface of the
container.
How quarantined materials are
segregated from other materials.
8.9 Sch-M
How access to quarantined area is
restricted.
Specify the system followed for
8.10 Sch-M
storing passed raw materials.
Whether proper racks, bins and
8.11 Sch-M platforms have been provided for
the storage.
Page 11 of 64
What is the control on entry of
material and men into the
WHO sampling area? Whether reverse
8.12
TRS-986 LAF have been provided for
sampling. Whether log book for
sampling booth maintained.
8.13 Sch-M provided for primary packaging
materials.
Specify the arrangements
provided to sample the primary
8.14 Sch-M
packaging materials foils, bottles,
etc. which are used as such.
WHO
8.15 Specify sampling plan used.
TRS-986
Which type of sampling tools are
WHO
8.16 used and how they are cleaned,
TRS-986
dried and maintained.
How containers are cleaned
before and after sampling.
WHO
8.17 (Specify whether the sampling is
TRS-986
carried out as per the current
SOP).
What provisions have been made
for segregated storage of rejected,
8.18 Sch-M recalled or returned materials or
products. How is the access to
these areas restricted?
How printed secondary packaging
8.19 Sch-M materials are stored in safe,
separate and in secure manner.
How printed packaging materials,
product leaflets etc. are stored
8.20 Sch-M
separately to avoid chances of
mix-up?
How labels, cartons, boxes,
8.21 Sch-M circulars, inserts and leaflets are
controlled. ?
How records of receipt of all
8.22 Sch-M labelling and packaging materials
are maintained.
Whether unused packaging
8.23 Sch-M materials return to the store or
destroyed.
How returned/unused packaging
material like foils is controlled so
8.24 Sch-M
as to prevent contamination and
cross- contamination.
Page 12 of 64
Specify the arrangement provided
8.25 Sch-M for dispensing of starting
materials.
What is the control on entry of
material and men into the
WHO dispensing area? Whether reverse
8.26
TRS-986 LAF have been provided for
dispensing with back ground clean
air supply.
Whether pressure differential is
WHO
8.27 maintained between the
TRS-986
dispensing and adjacent areas.
WHO Specify the pressure differential
8.28
TRS-986 maintained.
Examine the record of the daily
8.29 Sch-M check of balances in the
dispensing area.
How containers are cleaned
WHO
8.30 before and after dispensing. Who
TRS-986
carries out the dispensing?
Specify whether appropriate air
velocity is maintained in sampling
WHO & dispensing areas which rule out
8.31
TRS-986 any influence in the balance
readings placed inside the RLAFs
Benches.
Specify whether the dispensing is
8.32 Sch-M
carried out as per the current SOP.
Specify whether dispensed
material for each batch of final
8.33 Sch-M
product are kept together and
conspicuously labelled.
What steps are taken against
8.34 Sch-M spillage, breakage and leakage of
containers?
How highly hazardous, poisonous
and explosive materials, narcotics,
8.35 Sch-M and psychotropic drugs are
handled and stored. How these
areas are safe and secure.
9
Please specify the procedures
followed for receiving and
9.1 Sch-M processing of in-coming materials
(Starting materials and packing
material). Verify the SOP.
Whether first in / first out or first
9.2 Sch-M
expiry principal has been adopted.
Page 13 of 64
How they are labelled and stored
9.3 Sch-M as per their status – Under Test,
Approved and Rejected
Whether incoming materials are
9.4 Sch-M purchased from approved
vendors.
Whether list of approved vendors
9.5 Sch-M
is available to the user.
WHO Specify the norms of vendor
9.6
TRS-986 qualification.
How damaged containers are
9.7 Sch-M identified recorded and
segregated
Whether each batch of a
9.8 Sch-M consignment is considered for
sampling, testing and release.
Whether all the containers of each
WHO
9.9 batch of starting materials
TRS-986
sampled for identification test.
Whether labels of raw material in
the storage area have information
like;
a) designated name of the product
and the internal code reference,
where applicable, and analytical
reference number;
9.10 Sch-M b) manufacturer’s name, address e)
and batch number;
c) the status of the contents (e.g.
quarantine, under test,
released, approved, rejected);
and
d) The manufacturing date, expiry
date and re-test date.
Whether separate areas are
9.11 Sch-M provided for under test, approved
and rejected materials.
How the containers from which
9.12 Sch-M samples have been drawn
labelled.
Please specify the procedures by
which it is ensured that the raw
materials which has been released
9.13 Sch-M by the Quality Control Department
and which are within their shelf life
are going to be used in the
product.
10
Page 14 of 64
Verify whether access to
WHO
10.1 production area is restricted to
TRS-986
authorized personnel only.
Whether the facility is provided
WHO with a well-sealed structure with no
10.2
TRS-986 air leakage through ceilings,
cracks or service penetrations.
Whether entry and exit doors, for
materials and personnel, have an
WHO interlock mechanism or other
10.3
TRS-986 appropriate system to prevent the
opening of more than one door at
a time.
Specify the procedures for entry of
WHO
10.4 maintenance people into the
TRS-986
production area.
Whether the change rooms have
WHO
10.5 an arrangement with step-
TRS-986
over/cross-over bench.
Is there any cris-cross flow of
10.6 Sch-M
materials and men?
Whether the premises and
equipment are appropriately
10.7 Sch-M
designed and installed to facilitate
cleaning and decontamination.
WHO Specify the position of IPQC lab in
10.8
TRS-986 the manufacturing area.
Specify whether non storage
10.9 Sch-M areas are used for storage of any
material.
Specify the provisions for storage
WHO
10.10 of dirty, washed and cleaned
TRS-986
equipment in process areas.
Specify how service lines are
10.1 Sch-M identified for nature of supply and
direction of the flow.
Whether service lines in
production areas are through
WHO
10.12 service pendants. If not, how they
TRS-986
are placed so as to avoid
accumulation of dust.
11
Page 15 of 64
Please specify whether following
parameters are qualified:
⎯ (IQ, OQ, PQ)
⎯ Temperature
⎯ Relative humidity
⎯ supply air quantities for all
diffusers
⎯ return air or exhaust air
quantities
⎯ room air change rates
WHO
11.1 ⎯ room pressures (pressure
TRS-986
differentials)
⎯ room airflow patterns
⎯ unidirectional flow velocities
⎯ filter penetration tests (HEPA)
⎯ room particle counts
⎯ room clean-up rates
⎯ microbiological air and surface
counts where appropriate
⎯ operation of de-dusting
⎯ warning/alarm systems
WHO Verify the SOPs for AHUs
11.2
TRS-986 operation and cleaning.
Specify whether the facilities and
premises have following basic air-
handling characteristics:
a) The absence of direct venting of
air to the outside.
b) Whether the facility is
maintained at a negative air
pressure to the environment.
c) The precaution taken to prevent
the infiltration into the core
areas.
d) Whether appropriate air
WHO
11.3 pressure alarm systems as well
TRS-986
as alert and action limit is
provided.
e) The type of HEPA filters used in
the HVAC system
f) Whether the change rooms are
supplied with the same quality
of air as supplied to the working
area.
g) The measures taken to prevent
air flow from the primary
packing area to the secondary
packing area.
Page 16 of 64
Whether HVAC system
description includes:
1) Schematic drawings detailing
WHO
11.4 the filters and their
TRS-986
specifications
2) Number of air changes per hour
3) pressure gradients
WHO Specify the emergency power
11.5
TRS-986 systems in case of power failure.
Specify whether recirculated air is
WHO
11.6 used. If yes, specify the proportion
TRS-986
of fresh air supplied.
Whether risk assessment study
WHO has been carried out in case of
11.7
TRS-986 return air/ recirculated air system.
Verify the records thereof.
WHO Specify what precaution has been
11.8
TRS-986 taken during filter change of AHUs.
Whether all exhaust systems from
the facility, including dust
extraction systems, vacuum
system exhaust, fluid bed drier
WHO
11.9 exhaust, coating pan exhaust, 1
TRS-986
etc., are passed through safe
change filter housings and wet
scrubber before being exhausted
to the atmosphere.
Whether all exhaust points outside
the building are located as far as
WHO possible from air entry points, exit
11.10 2
TRS-986 points and at a high level, to
minimize the possibility of re-
entrainment of exhaust air.
Whether the return air ducts are

WHO
11.1 checked periodically for dust X
TRS-986
accumulation.
Whether the dust collectors are

11.11 Sch-M located in a room maintained at a X
negative pressure.
Page 17 of 64
Whether the filters cleaning facility
WHO
11.12 is maintained at negative 1
TRS-986
pressure.
Whether records for safe disposal
WHO
11.13 of all contaminated filters and dust 1
TRS-986
are maintained.
Specify whether total No. of AHUs
WHO used to cover the whole production
11.15 X
TRS-986 Area is commensurate with the
requirements.
WHO Specify the Terminal Air Filter of
11.16 2
TRS-986 various core areas.
WHO Specify the no. of Air Change
11.17 2
TRS-986 maintained in various core areas.
WHO Specify the pressure balancing to
11.18 2
TRS-986 segregate different areas.
WHO Are the returns risers cleaned
11.19 2
TRS-986 during Product Change Over?
Verify if the AHU's / HVAC
systems have been shut down. If
WHO yes, the reasons there of such as
11.20 2
TRS-986 cleaning & maintenance & the
procedures for re-initiation / re-
start of the systems
12 Cleaning Validation: -
Cleaning validation was done as
Is a validation performed to
12.1 Sch-M per SOP no LP/QA-39 for 2
confirm cleaning effectiveness?
cleaning validation.
The firm has maintained protocol
Does the protocol define the
which define the selection criteria
WHO selection criteria for products or
12.2 for products or groups of 2
TRS-986 groups of products subject to
products subject to cleaning
cleaning validation?
validation.
Is data produced supporting the The report produced by the firm
WHO
12.3 conclusion that residues were shown that residues were 2
TRS-986
removed to an acceptable level? removed to an acceptable level.
Specify whether the validation is
implemented to verify cleaning of:
Type A cleaning for batch to
WHO 1) Surfaces in contact with the
12.4 batch change and type B for 2
TRS-986 product
product change .
2) After a change in product
3) Between shift batches.
Specify whether the Validation Cleaning validation includes dirty
WHO
12.5 Strategy include contamination hold time and cleaned hold time 2
TRS-986
risks & equipment storage time. studies for equipments.
Whether Quality Control
WHO shown Quality Control were
12.6 responsible of the sampling for 2
TRS-986 responsible of the sampling for
cleaning verification?
cleaning verification
Page 18 of 64
WHO Whether personnel engaged in showed personnel engaged in
12.7 2
TRS-986 cleaning, sampling etc. trained. cleaning, sampling etc. were
trained
Specify whether acceptance limits The record produced by the firm
been set for cleaning verification showed that acceptance limits
WHO and are based on following criteria: were based on following criteria:
12.8 2
TRS-986 1) Visually clean. 4) Visually clean.
2) 10 ppm in another product. 5) 10 ppm in another product.
3) 0.1% of the therapeutic dose? 6) 0.1% of the therapeutic dose?
Specify whether detergent The record produced by the firm
WHO residues and degradation showed that conductivity and PH
12.9 2
TRS-986 products are investigated during were done to detergent residues
validation. and degradation products.
Whether validation records The record produced by the firm
include: showed that validation records
Recovery study data, Analytical include: Recovery study data,
method, Acceptance Criteria, Analytical method, Acceptance
WHO Swab recovery test, Signatures of Criteria, Swab recovery test,
12.10 2
TRS-986 the Quality Assurance Manager, Signatures of the Quality
Signature of the employee in Assurance Manager, Signature
charge of cleaning verification of the employee in charge of
from Production and Quality cleaning verification from
Control. Production and Quality Control.
13 Manufacturing Operations and Controls: -
Whether the contents of all vessels
Vessels and containers used in
and containers used in
manufacture and storage is
manufacture and storage is
conspicuously labelled with the
conspicuously labelled with the
13.1 Sch-M name of the products. Batch no, 2
name of the products. Batch no,
Batch Size, and stage of
Batch Size, and stage of
manufacture along with signature
manufacture along with signature
of technical staff.
of technical staff.
The firm has not carried out
pathogen specific test for
Whether the products not finished product which
prepared under aseptic conditions concludes that products not
13.2 Sch-M are free from pathogens like prepared under aseptic 0
Salmonella, Escherichia coli, conditions are free from
Pyocyanea etc. pathogens like Salmonella,
Escherichia coli, Pyocyaneaetc
If yes, pls give a brief account of

13.3 Sch-M measures taken to assure -
freedom from pathogens.
Verify whether handling of
WHO materials and products are carried The firm has various SOPs for
13.4 2
TRS-986 out in accordance with the relevant handling of materials.
SOP’S.
Page 19 of 64
As per records produced by the
Specify Whether any deviation is
WHO firm, deviation was approved in
13.5 approved in writing by a 2
TRS-986 writing by a designated person
designated person and recorded.
and recorded.
The firm has SOP no LP/QA-065
WHO Is there an approved SOP for In
13.6 for procedure for in process 2
TRS-986 process check?
check.
Is the personnel clothing clean, It was found that personnel
WHO
13.7 unstained & dust free, including clothing were cleaned, unstained 2
TRS-986
shoes? & dust free, including shoes.
Is there a cleaning SOP for SOP no LP/SOP/PAD-020
WHO
13.8 slippers or shoes that is being procedure for footwear cleaning 2
TRS-986
used in the manufacturing area? maintained.
Whether process hold time studies SOP no PL/QA-061 Procedure
WHO
13.9 has been carried out for various for Hold time studies were 2
TRS-986
stages of production maintained.
14 Precautions against mix-up and cross-contaminations: -
In the RM store for general
Tablets & Capsules block,the
Whether proper AHU, pressure sampling and dispensing area
differential, segregation, status
has common AHU. It was found
labelling have been provided to
14.1 Sch-M 0
prevent mix-up and cross- that common AHU provided in
contamination in manufacturing the Blister 1 of Beta Lactum
area Capsules Machine area and
strip machine area.
Granulation, compression,
Pls specify the areas of dust capsule filling and dusting
14.2 Sch-M generation and mechanism powder filling area generate dust 1
involved in controlling the dust and it was found that return riser
were provided in said areas.
Do all the areas have their own
Air locks provided for men and
14.3 Sch-M independent air locks separately 2
material entry
for men and material entry.
Pressure differential has been
found set for production v/s
adjoining areas. However, during
What criterion of pressure visit at granulation and
14.4 Sch-M differential has been set for compression areas of non beta- 0
production v/s adjoining areas. lactum pressure gauges were not
found working and production
was going on, no deviations were
taken.
Page 20 of 64
Whether processing of sensitive It was found that processing of
drugs like Beta lactam Antibiotics sensitive drugs like Beta lactam
and Sex Hormones is done in Antibiotics and Sex Hormones
segregated areas with was done in segregated areas
14.5 Sch-M independent AHU and proper with independent AHU and 2
pressure differentials along with proper pressure differentials
demonstration of effective along with demonstration of
segregation of these areas with effective segregation of these
records. areas with records.
Please specify what measures has
been taken to prevent The firm has provided SOP no
contamination of products with LP/QA- 26 for prevention of
14.6 Sch-M 2
Beta Lactam Antibiotics, Sex product mix up and cross
hormones and cyto-toxic contamination provided.
substances.
What measures has been taken to SOP no LP/QA- 26 for prevention
14.7 Sch-M prevent mix-ups during various of product mix up and cross 2
stages of production. contamination provided
Whether equipments use for It was found that equipments use
14.8 Sch-M production are labelled with their for production are labelled with 2
current status. their current status
Whether packaging lines are It was found that packaging lines
14.9 Sch-M independent and adequately are independent and adequately 2
segregated. segregated
It was found that line clearance
How line clearance is performed.
was performed. Records of line
Whether records of line clearance
14.10 Sch-M clearance were maintained 2
are maintained according to
according to the appropriate
appropriate checklist.
checklist.
Whether separate carton coding It was found that a separate
area has been provided or online carton coding area has been
14.11 Sch-M carton coding is performed provided . QA has a procedure to 2
How carton coding procedure is control carton coding vide SOP
controlled. no PL/SOP/PBI-027.
Please specify how temperature,
humidity and air filtration are Temp and humidity was
14.12 Sch-M controlled in the areas where raw monitored twice a day for critical 2
material and/or products are areas.
exposed and handled.
How access of authorized persons
List of authorized persons found
14.13 Sch-M to manufacturing areas including 2
maintained.
packaging is controlled.
Whether separate gowning It was found that separate
14.14 Sch-M provision is followed before gowning provision is followed 2
entering the core areas. before entering the core areas
Page 21 of 64
Whether segregated secured It was found that secured areas
areas for recall or rejected for recall or rejected materials or
14.15 Sch-M materials or for such material for such material which are to be 2
which are to be processed or processed or recovered are
recovered are provided. provided.
It was found that various
Whether various operations are
14.16 Sch-M operations are carried out in 2
carried out in segregated areas.
segregated areas.
The firm has not provided door
Are doors of all core areas closed
interlocking facility at General
14.17 Sch-M at all times with interlock 0
Non Beta-lactam and Beta-
arrangements?
lactum section
Specify whether any SOP is
SOP no LP/QA- 26 for prevention
followed to verify the effectiveness
14.18 Sch-M of product mix up and cross 2
for prevention of cross
contamination provided.
contamination.
It was found that critical
WHO Specify whether critical operations
14.19 operations are carried out in 2
TRS-986 are carried out in closed system.
closed system
SOP no LP/PC-002 provided for
WHO Specify the methods followed for
14.20 cleaning and product change 2
TRS-986 product change-over.
over.
15 Sanitation in the Manufacturing areas: -
Specify the cleaning procedure of The firm has provided SOP No-
15.1 Sch-M the manufacturing areas and verify LP/QA-039 for cleaning 2
with the SOP in this regard. validation.
Whether the cleaning procedure is
15.2 Sch-M firm, cleaning procedure was 2
validated.
validated.
Whether a routine sanitation
15.3 Sch-M firm, a routine sanitation 2
program is in place.
program is in place
No LPL/SOP/PAD-001& SOP
No LPL/SOP/NPS-007 for
Verify the SOP & the records in
15.4 Sch-M routine sanitation and records of 2
this regard.
routine sanitization was
produced.
It was found that the location
Does the location facilitate
facilitate cleaning of equipment
cleaning of equipment as well as
15.5 Sch-M as well as the cleaning of the 2
the cleaning of the areas in which
areas in which they were
they are installed?
installed.
Whether the production area is It was found that production area
15.6 Sch-M 2
adequately lit. was adequately lit
Production area and other area
Mention lux levels observed in
s - LUX Levels not less than
15.7 Sch-M production, visual inspection and 2
300 and for visual inspection
other areas.
3000 Lux
Page 22 of 64
Specify in detail the procedure SOP no LP/PC-002 provided for
15.8 Sch-M followed during product cleaning and product change 2
changeover. over.
16 Equipment: -
It was found that equipment
Whether the equipment are
were designed aiming to
designed aiming to minimize risk
minimize risk of error and permit
of error and permit effective
16.1 Sch-M effective cleaning and 2
cleaning and maintenance in order
maintenance in order to avoid
to avoid cross contamination &
cross contamination & buildup of
buildup of dust.
dust
Whether all equipment are It was found that all equipment
16.2 Sch-M 2
provided with log book. were provided with log book
Please specify the procedures to SOP no LP/PC-002 provided for
16.3 Sch-M clean the equipment after each cleaning and product change 2
batch production. over
Whether validity period for use It was found that validity period
16.4 Sch-M after the cleaning of equipment is for use after the cleaning of 2
specified. equipment was specified.
It was found that separate area
Whether separate area is provided
16.5 Sch-M is provided for storage of 2
for storage of machine parts etc.
machine parts etc
Whether balances and other
measuring equipments with
appropriate range are available in
the Raw Material stores & Produced SOP for LP/QC/-065
16.6 Sch-M production areas and they are for calibration, operation and 2
calibrated in accordance with SOP cleaning of balance
maintained. Specify the
calibration schedule of the
balances.
Specify material of construction of
16.7 Sch-M contact parts of the production SS 316L, SS 316 and SS 304 2
equipments.
Which types of lubricants are used
in the equipment. Specify the Firm informed that Food grade
16.8 Sch-M 2
quality and control reference No. lubricants were used.
of these lubricants.
The firm has not
Specify the procedures to remove
procedures/SOP to remove
16.9 Sch-M defective equipments from 1
defective equipments from
production areas.
production areas
Verify whether washing and
WHO
16.10 cleaning of equipment are not a Swap testing was carried out to 2
TRS-986
source of contamination.
Whether all equipment is provided It was found that all equipment
16.11 Sch-M 2
with an ID NO. were provided with an ID NO
Page 23 of 64
Specify the procedures to clean
WHO the equipment after each batch Type A/Type B cleaning was
16.12 2
TRS-986 production and verify with the done as per SOP LP/PE-001
SOP.
WHO Specify whether CIP or SIP is in
16.13 CIP and SIP was in place 2
TRS-986 place.
WHO Specify whether the CIP / SIP Cleaning validation was carried
16.14 1
TRS-986 system is qualified out.
Are there cleaning agent labelled It was found that the cleaning
WHO with a catalogue no. indicating that agent labelled with a catalogue
16.15 2
TRS-986 they were received through the no. indicating that they were
warehouse. received through the warehouse.
WHO Are there records for preparation The firm has produced records
16.16 2
TRS-986 of cleaning agent? for preparation of cleaning agent
17 Production Area for Sterile Preparation
17.1 Building and Facilities: -
No cracks in the Aseptic solutions
preparation rooms, Filling rooms,
Sealing rooms was observed.
The firm was holding the valid

product permission for
Manufacturing of Dry Powder
Injection (General Category)
however no section was
endorsed under plan layout and
Specify the building is devoid of
no area was provided for
cracks especially in the Critical
17.2 Sch-M Manufacturing of Dry Powder X
solutions preparation rooms, filling
Injection (General Category). As
rooms, Sealing rooms.
per BMR issuance register, it was
found that they have
manufactured 04 batches of
Pantoprazole Dry Powder
Injection from last 5 yearsand
even the firm has not produced
the product permission issued by
SLA for manufacturing of
Pantoprazole Dry Powder
Injection.
It was found that the locations of
Are the locations of services like
services like water, steam,
water, steam, gases etc. Such that
gases etc. Such that the
17.3 Sch-M the servicing or repairs can be 2
servicing or repairs can be
carried out without any threat to
carried out without any threat to
the integrity of the facility
the integrity of the facility
The water lines did not pose
Specify water lines pose any threat
17.4 Sch-M any threat of leakage to the 2
of leakage to the critical area
critical area
Page 24 of 64
Specify the manufacturing areas
clearly separated into following
Support Areas: Firm has provided the provision
1) Washing of containers & in the manufacturing area to
closures maintain the required class of
2) Storage of washed containers area in the manufacturing facility.
17.5 Sch-M 2
& closures i.e. manufacturing /mixing area
3) Sterilization of containers & class C, filtration, filling and
closures sealing class A (Background
4) Preparation of bulk solution class B).
(critical/non critical)
5) Change room
Specify de-cartoning areas to The firm has provided de-
remove outer cardboard cartoning areas to remove outer
17.6 Sch-M wrappings of primary packaging cardboard wrappings of primary 2
materials segregated from the packaging materials segregated
washing areas. from the washing areas.
It was found that particle
Specify whether particle shedding
shedding materials like wooden
materials like wooden pallets, fibre
17.7 Sch-M pallets, fibre board drums, 2
board drums, cardboards etc. are
cardboards etc. were not taken
taken into the preparation areas.
into the preparation areas
The following was found that -
Specify in the classified areas:
Walls are flat, smooth and
1) Walls are flat, smooth and
devoid of recesses.
devoid of recesses.
1-Walls are flat, smooth and
2) Surface joints like electric
devoid of recesses
sockets, gas points flushed
2-Surface joints like electric
with walls.
sockets, gas points flushed with
3) Joints in the ceiling are
walls.
properly sealed
3-Joints in the ceiling are
4) Air grills and lights flushed with
17.8 Sch-M properly sealed 2
the ceiling.
4-Air grills and lights flushed with
5) Grade A & B areas devoid of
the ceiling.
sinks and drains.
5-Grade A & B areas devoid of
6) Doors and windows made up
sinks and drains.
of non-shedding materials.
6-Doors and windows made up of
7) Doors open towards higher
non-shedding materials.
pressure areas and close
7- Doors open towards higher
automatically due to air
pressure areas and close
pressure.
automatically due to air pressure.
Is there a glass panel between It was found that a glass panel
WHO
critical area & support area so that between critical area & support
TRS-961
17.16 all operations in Grade A & B area so that all operations in 2
ANNEXE-
areas can be supervised from Grade A & B areas can be
06
support areas? supervised from support areas
Page 25 of 64
WHO
Fire extinguishers were suitably
TRS-961 Fire extinguishers are suitably
17.17 fastened to the walls without 2
ANNEXE- fastened to the walls without gaps.
gaps.
06
Quality of the furniture used is Quality of the furniture used was
17.18 Sch-M smooth & washable and made of smooth & washable and made of 2
SS316. SS316
Change rooms entrance provided It was found thatv change rooms
with air locks before entry to the entrance provided with air locks
17.19 Sch-M 2
sterile product manufacturing before entry to the sterile product
areas. manufacturing areas.
How many change rooms are Three change rooms were
17.20 Sch-M provided to enter into the critical provided to enter into the critical 2
areas? areas
Specify an appropriate inter- Provided appropriate inter-
WHO
locking system with visual and/or locking system with visual and/or
TRS-961
17.2 audible warning system installed audible warning system installed 2
ANNEXE-
to prevent the opening of more to prevent the opening of more
06
than one door at a time. than one door at a time.
It was found that the critical and
Are the critical and support areas
support areas provided with
provided with intercom telephones
17.2 Sch-M intercom telephones or speak 2
or speak phones for
phones for communication
communication purposes.
purposes.
Specify the critical areas and
Critical areas and support areas
support areas provided with
provided with suitable airlocks
suitable airlocks or pass boxes
17.2 Sch-M or pass boxes with proper 2
with proper interlocking
interlocking arrangements for
arrangements for material
material transfer.
transfer.
WHO
Specify whether dynamic pass box Provided dynamic pass box
TRS-961
17.2 is used for material transfer used for material transfer 2
ANNEXE-
between two different air class. between two different air class
06
Specify the method of transfer of Sanitisation by 70% IPA and
17.3 Sch-M sterile rubber bungs & aluminum provided pass box through UV 2
caps to the aseptic area. treatment
It was found that the grade A/B
Specify whether grade A/B area is
17.3 Sch-M area was devoid of sinks and 2
devoid of sinks and drains.
drains.
18 Air Handling System (Central Air Conditioning): -
It was found that the Air Handling
Specify whether the Air Handling
Units for sterile product
Units for sterile product
18.1 Sch-M manufacturing area were 2
manufacturing area are separated
separated from those for other
from those for other areas
areas
Page 26 of 64
Give the Background Grade of air
Aseptic filling area- Background
for following critical areas:
grade B
1) Aseptic filling area
Sterilized components unloading
2) Sterilized components
area for aseptic filling. Grade A/B
unloading area for aseptic
Batch manufacturing area for
filling.
18.2 Sch-M aseptic filling preparations- 2
3) Batch manufacturing area for
Grade C
aseptic filling preparations.
Component washing and
4) Component washing and
preparation area- Grade C/D
preparation area.
Change rooms to enter into
5) Change rooms to enter into
Critical area- Garde B/C
Critical area.
WHO Specify the steps taken in air
Provided AHUs to achieve the
TRS-961 handling system to achieve the
18.3 Grade A, B, C and D of air as 2
ANNEXE- Grade A, B, C and D of air as per
per designated classified areas
06 designated classified areas.
Specify the recovery time of B & C
zone from the time of personnel
18.4 Sch-M leaving the room after completion No such records provided. 1
of operations and verify the
records in this regard.
Specify whether filling operations
firm, filling operations were
are challenged initially and there
18.5 Sch-M challenged initially and there 2
after periodically by simulation
after periodically by simulation
trials including sterile media fill.
trials including sterile media fill.
WHO
Specify the procedure followed for
TRS-961 SOP for LP/QA-063 for medial
18.6 medial fill and the acceptance 2
ANNEXE- fill
criteria.
06
As per record produced by the
Whether the medial fill trial is
firm, medial fill trial was based
WHO based on worst case situation
on worst case situation taking
TRS-961 taking into consideration all
18.7 into consideration all 2
ANNEXE- interventions, activities occurring
interventions, activities occurring
06 during normal activity as well as
during normal activity as well as
worst case.
worst case
Whether simulation tests are
WHO
repeated at defined intervals and
TRS-961 As per records produced by firm
18.8 after any significant modification to 2
ANNEXE- at frequency of 6 months
HVAC system, equipment or
06
process.
As per records produced by firm
Specify the number of air changes
18.9 Sch-M for Garde A/B NLT 70 and 2
in Grade A/B and Grade C areas.
Grade C NLT 40 ACPH
As per records produced , Air
Specify the air velocity maintained
velocity maintained in Grade A
18.10 Sch-M in Grade A Laminar Air Flow 2
Laminar Air Flow stations was
stations
found 0.3 meter per second
Page 27 of 64
Between same classes NLT 1.0
Specify the differential pressure
mm water gauge and for
18.1 Sch-M between areas of different 2
different classes NLT 1.5 mm
environmental standards.
water gauge
Specify type of manometer
Provided manometer installed
installed for measurement and
18.1 Sch-M for measurement and verification 2
verification of Air Pressure
of Air Pressure Differential.
Differential.
WHO
TRS-961 Specify the air classification in final
18.13 Grade B 2
ANNEXE- change room to enter A/B area.
06
19 Environmental Monitoring: -
Specify the temperature and
Temp MLT 25 C and RH NMT
19.1 Sch-M humidity maintained in the critical 2
40%
areas.
Verify the area qualification
records and specify whether the
following were taken into
consideration:
1) No. of Persons
2) ACPH (Air Changes per hours)
3) Particle count (Static &
Dynamic)
WHO
4) Viable count (Static &
TRS-961 No number of persons were
19.2 Dynamic) 1
ANNEXE- considered.
5) Temperature & Humidity
06
6) Air Sampling location and
interpretation of results (Both
viable and non-viable)
7) Whether the above method is
in compliance with ISO 14644-
1
8) Action and Alert limits for all the
above parameters.
1-Particulate Counts- 6 months
Mention the periodic monitoring
2-HEPA filters integrity testing-
frequencies of the followings:
01 years
1) Particulate Counts
3-Air Change rates- 6 months
2) HEPA filters integrity testing
4-Air pressure differentials- Daily
3) Air Change rates
19.3 Sch-M 5-Temperature and Humidity- 2
4) Air pressure differentials
Daily
5) Temperature and Humidity
6-Microbiological monitoring by
6) Microbiological monitoring by
settle plates and/ or swabs in
settle plates and/ or swabs in
Critical areas & Other areas-
Critical areas & Other areas
Daily (In injectable area only)
SOP no LP/QA-035 for
Does a written Environmental
19.4 Sch-M Environmental Monitoring 2
Monitoring Program exist?
Program
Page 28 of 64
How long the settle plates are
19.5 Sch-M exposed in Grade A and other Minimum 4 hrs. 2
areas.
Verify the records of The firm has produced records
microbiological results also specify of microbiological results also
19.6 Sch-M 2
whether alert and actions limits are specify alert and actions limits
followed or not. were followed
What action is taken in case
particulate and microbiological As per information produced by
19.7 Sch-M 2
monitoring counts exceed the the firm no such deviation found
limits?
Specify what parameters are
WHO reassessed and approved before
TRS-961 starting production and in case of Area re-qualification to be
19.8 2
ANNEXE- major engineering modifications carried out
06 being carried out to the HVAC
system of any area.
20 Garments:
Specify type of garments used in Lint free Sterile garments used
20.1 Sch-M 2
critical areas? in critical areas
Specify type of Zips used in
20.2 Sch-M Zips not used in garments 2
garments
Whether garments used in critical It was found that garments used
20.3 Sch-M 2
areas are sterile. in critical areas are sterile
Specify the process of sterilization
SOP no. LPL/SOP/QCM-022 for
of the garments & the practice
20.4 Sch-M sterilization of the garments 2
followed to carry the sterilised
provided
garments to the final change room.
It was found that garments,
Are garments, masks, gloves are
20.5 Sch-M masks, gloves were changed at 2
changed at every work session?
every work session
Are the gloves used made of latex
20.6 Sch-M Gloves are made of latex 2
or other suitable plastic material
Are powder free gloves used in Powder free gloves used in clean
20.7 Sch-M 2
clean rooms rooms
Are the gloves long enough to
Gloves long enough to cover the
cover the wrists completely and
20.8 Sch-M wrists completely and allow the 2
allow the over-all cuff to be tucked
over-all cuff to be tucked in
in
Are the foot-wear used made of Foot-wear used made of rubber
20.9 Sch-M 2
plastic or rubber material material
Foot-wear daily cleaned with a
Are the foot-wear daily cleaned
20.10 Sch-M bactericide 2
with a bactericide
Does the safety goggles / The safety goggles / numbered
20.1 Sch-M numbered glasses worn inside the glasses worn inside the critical 2
critical areas have side extensions areas have side extensions.
Page 29 of 64
It was found safety goggles
Are safety goggles sanitized by a
20.1 Sch-M sanitized by a suitable method- 2
suitable method
Autoclave
Specify the garment changing As per SOP No LPL/SOP/QCM-
20.1 Sch-M 2
procedure documented 022
Specify whether operators are
As per SOP No LPL/SOP/PBI-
20.1 Sch-M trained in garment changing 2
037
procedure.
Specify a full-size mirror been Provided full-size mirror been
provided in the final change room provided in the final change
20.2 Sch-M to ascertain that the operator has room to ascertain that the 2
appropriately attired in the operator has appropriately
garments. attired in the garments
WHO
Specify how the garments used in SOP no. LPL/SOP/QCM-022 for
TRS-961
20.2 clean areas are cleaned and sterilization of the garments 2
ANNEXE-
sterilized. provided
06
21 Sanitation:
Specify the SOP followed for
sanitation of sterile processing
21.1 Sch-M SOP No- LPL/SOP/NPS-007 2
facilities and mention the SOP
nos.
Specify whether employees It was found that employees
carrying out the sanitation of carrying out the sanitation of
21.2 Sch-M 2
critical areas are specially trained critical areas were specially
for this purpose. trained for this purpose
21.3 Sch-M Verify the training records.
Specify the sanitizing agent/s Verosil 20% for area sanitization
21.4 Sch-M 2
used.
Specify the quality of water used
WFI used for preparation of
21.5 Sch-M for preparation of sanitising 2
sanitising solution
solution.
IPA 70% disinfectant used for
hand sprays. However it was
found that the firm has carried
Specify the disinfectant used for out validation/efficacy test of IPA
21.6 Sch-M 1
hand sprays? 70 % solution used for
sanitization purpose.
Specify whether disinfectant

Disinfectant solutions were
solutions are filtered through
filtered ) through membrane into
21.7 Sch-M membrane into suitable sterile 2
suitable sterile containers or
containers or sterilized before
sterilized before use.
use?
Page 30 of 64
Specify whether the diluted
disinfectants bear ‘use before’ It was found that diluted
21.8 Sch-M labels based on microbiological disinfectants bear ‘use before’ 2
establishment of their germicidal labels.
properties & verify the records
Specify whether fumigation is
Fumigation was carried out in
carried out in critical areas. If yes,
21.9 Sch-M critical areas Verosil 20% for 2
specify fumigating agent and its
area sanitisation.
conc. used.
Specify whether any SOP exist for
21.10 Sch-M the purpose of fumigation if so SOP No- LPL/SOP/NPS-016 2
mentioned the SOP nos.
SOP No- LPL/SOP/NPS-038 for
Specify the cleaning procedure of
21.1 Sch-M cleaning procedure of critical 2
critical areas.
areas
The firm has not produced
Specify whether particle
WHO records for particle monitoring in
monitoring in Grade A zones is
TRS-961 Grade A zones undertaken for
21.1 undertaken for the full duration of 1
ANNEXE- the full duration of critical
critical processing including
06 processing including equipment
equipment assembly.
assembly
WHO Specify whether particle
records of particle monitoring in
TRS-961 monitoring in Grade B zones is
21.1 Grade B zones undertaken for 1
ANNEXE- undertaken for the full duration of
the full duration of critical
06 critical processing.
processing.
Whether more than one sanitizing
As per SOP No LP/PD-003 more
agent is used in rotation. If yes list
21.1 Sch-M than one sanitizing agent was 2
the sanitizing agents their
used in rotation .
concentration and frequency.
22 Equipment:
Specify whether the unit-
It was found the unit- sterilizers
sterilizers are double ended with
22.1 Sch-M were double ended with suitable 2
suitable inter-locking between the
inter-locking between the doors
doors.
As per SOP no LP/QM-006, for
Specify the initial effectiveness of autoclave -
sterilization process established GeobacillusStearothermophilus
22.2 Sch-M 2
by using microbial spore ATCC 7953 and for DHS
indicators. Bacillus Atrophaeus microbial
spore as indicators were used.
Specify whether thermal Mapping As per records produced thermal
22.3 Sch-M of heat sterilizers is carried out on Mapping of heat sterilizers was 2
regular basis. Check records. carried out on regular basis
As per records produced,
Specify suitable vent filters and
suitable vent filters and recording
22.4 Sch-M recording thermographs provided 2
thermographs provided in
in autoclaves & dry sterilizers.
autoclaves & dry sterilizers.
Page 31 of 64
0.3 micron HEPA filters used for
Specify HEPA filters for cooling air
cooling air and recording
22.5 Sch-M and recording thermographs 2
thermographs provided in
provided in DHS/Tunnel.
DHS/Tunnel.
WHO
Firm has informed that they
TRS-961 Specify whether provisions of CIP
22.6 have provisions of CIP or SIP 2
ANNEXE- or SIP are available.
were available.
06
Specify whether pure steams are PSG was used for generation of
22.7 Sch-M 2
in use. pure steams
Specify filter integrity test carried
As per SOP No- LPL/SOP/NPS-
22.8 Sch-M out before and after the filtration 2
022
process.
Specify the material of
firm, Material of construction of
22.9 Sch-M construction of the equipment & 2
the equipment as SS 316 &
glass containers.
glass class 1 containers.
Specify the tubing used in critical Type A tubing used in critical
22.10 Sch-M 2
areas areas
Validation of autoclave shown.
Specify the qualifications of critical
22.1 Sch-M Graphs of bowie dick test not 1
equipment.
produced.
WHO Performance re-qualification
Verify the qualification, protocol
TRS-961 report , protocol LP/PQ/ACV/P-
22.1 and reports for the critical 2
ANNEXE- 001-01 for Autoclave ID No
equipment.
06 QCD/ALV/002 was verified
The firm has produced various
Specify SOPs available for each
SOPs for equipment operation
22.1 Sch-M equipment for its operation and 2
and cleaning.
cleaning.
Specify whether the measuring It was found that the measuring
22.1 Sch-M devices attached to equipment devices attached to equipment 2
calibrated at suitable intervals. calibrated at suitable intervals.
Specify whether a written
22.2 Sch-M SOP No LP/QA-027 2
calibration program is available
It was found that calibration
Specify whether calibration status
status documented and
22.2 Sch-M documented and displayed on the 2
displayed on the equipment and
equipment and the gauges
the gauges
23 Manufacturing Process
Specify whether the bulk raw
firm, bulk raw materials and bulk
materials and bulk solutions
solutions monitored for bio-
23.1 Sch-M monitored for bio-burden 2
burden periodically (solutions
periodically (solutions not to
not to contain more than 100
contain more than 100 cfu/ml).
cfu/ml)
Page 32 of 64
Specify the minimum possible time
between the preparation of the
23.2 Sch-M solution and its sterilization or 12 hrs. 2
filtration through microorganism
retaining filters followed.
Specify the porosity of the filters
when any external gases are
23.3 Sch-M 0.22 micron filter 2
coming into contact with the sterile
product.
It was found that gas cylinders
Specify whether gas cylinders are
23.4 Sch-M were kept out-side of the critical 2
kept out side of the critical areas.
areas
Specify the procedure of
23.5 Sch-M By Autoclave 2
sterilization of washed containers.
It was found that the sterilized
Specify whether the sterilized
containers not used within an
containers not used within an
23.6 Sch-M established time, rinsed with 2
established time, rinsed with WFI
WFI and re-sterilized.
and re-sterilized.
Is each lot of the finished product It was found that each lot of the
23.7 Sch-M filled in one continuation finished product filled in one 2
operation? continuation operation
Page 33 of 64
During review of product
validation, discrepancies were
found for the below product with
respect of batch size.
1.For product Trimzole DS

Tablets, process validation was
carried out with B. Size- 20.40
Lakhs Tabs and the B. Size for
actual manufacturing was 7.0
Lakhs tabs as per batch
manufacturing record.
2.For product Paracetamol 500

Tablets, process validation was
Specify whether all critical process Lakhs Tablets and the B. Size for
23.8 Sch-M 0
is validated. Verify the records. actual manufacturing was 12.24
Lakhs Tablets as per batch
3.For product MicolabTablets ,

process validation was carried
out with B. Size- 6.12 Lakhs
Tablets and the B. Size for
actual manufacturing was 4.0
4. For product Abide Plus
Tablets , process validation was
Lakhs Tablets and the B. Size
for actual manufacturing was 2.5
manufacturing record
process validation protocol and
reports of products- 1.
Testosterone Propionate
WHO Injection USP 25 mg
Verify the process validation
TRS-961 2. Testosterone Enanthate
23.9 protocol and reports for the critical X
ANNEXE- Injection USP 250 mg
operation.
06 3.Hydroxyprogesterone
Caproate Injection IP 100 mg
4. Iron Sucrose Injection USP
5. Grisolab Tablets ( Griseofulvin
250mg Tabs).
Page 34 of 64
WHO
It was found that critical
TRS-961 Specify whether critical operations
23.10 operations are carried out in 2
ANNEXE- are carried out in closed system.
closed system
06
24 Aseptic processing and sterilization by filtration:
It was found that the filling area
of Hormonal section was of
Grade Aenvironment with Grade
B background.
Specify whether the filling area is It was found there was no

24.1 Sch-M of Grade Aenvironment with separate entry and exit provided X
Grade B background. for the filtration room and
manufacturing room of the
Hormonal section. For batch
manufacturing area (Grade C)
person has to go through filling
room (Grade A/B).
Specify the room classification of
Grade A Under LAF background
24.2 Sch-M solutions preparation area which is 2
B
sterilized by filtration.
Sterile 0.45 and 0.22 micron
Specify the filter used for
24.3 Sch-M PES filters used for sterilization 2
sterilization of solution by filtration.
of solution by filtration.
WHO
TRS-961 Specify the maximum possible Maximum 6 hrs if there was a
24.4 2
ANNEXE- time used for filtration process. large batch size.
06
Specify whether integrity of the
It was found that integrity of the
sterilizing filters is verified before
24.5 Sch-M sterilizing filters was verified 2
and after use. If so, by which
before and after use
method.
Specify whether the personal
WHO As per the training records, the
working in the aseptic area is
TRS-961 personal working in the aseptic
24.6 qualified for clean room procedure 2
ANNEXE- area was qualified for clean
or not. If so, verify the training
06 room procedure
records.
25 Product Containers & Closures:-
Specify whether the containers The records produced by the
and closures used comply with firm, containers and closures
25.1 Sch-M 2
pharmacopoeia or other specific used comply with
requirements. pharmacopoeia
Specify whether Specifications,
Test methods, cleaning
procedures, Sterilizing procedures
25.2 Sch-M By Autoclave 2
etc. are available of the containers/
closures and other component
parts of drug packages.
Page 35 of 64
Specify whether the container & It was found that the container &
closures are compatible with the closures were compatible with
25.3 Sch-M 2
product without affecting its quality the product without affecting its
and purity. Verify the records. quality and purity.
Specify whether containers and It was found that containers and
25.4 Sch-M the closures are finally washed the closures were finally washed 2
with WFI before sterilization. with WFI before sterilization.
Specify whether a written
As per SOP no. LPL/SOP/PBI-
25.5 Sch-M procedure exist for washing of 2
006
glass ampoules/vials.
Specify whether the material It was found that the material
quality of the stoppers and quality of the stoppers and
25.6 Sch-M closures ensures that it does not closures ensures that it did not 2
affect the quality of the product affect the quality of the product
and avoids the risk of toxicity. and avoids the risk of toxicity.
26 Sterilization
Whether the sterilizing processes
It was found that sterilizing
have been validated (Dry heat,
26.1 Sch-M processes have been validated 2
Moist heat, filtration, ETO,
(Dry heat, Moist heat, filtration)
ionizations whichever applicable.
Whether the validity of the process
26.2 Sch-M verified at regular intervals (at Annually 2
least annually)
Whether the terminal sterilizer’s
capacity is sufficient to sterilize
one batch completely at one time.
26.3 Sch-M NA NA
If not specify controls and
measures taken in lot
sterilizations.
As per SOP no LP/QM-006, for
autoclave -
Whether biological indicators used GeobacillusStearothermophilus
26.4 Sch-M 2
in monitoring of sterilization. ATCC 7953 and for DHS
Bacillus Atrophaeus microbial
spore as indicators were used
WHO As per records produced by the
Verify that the probe is placed at
TRS-961 firm, probe was placed at the
26.5 the coolest point on the basis of 2
ANNEXE- coolest point on the basis of
validation studies
06 validation studies
WHO
The firm has produced
TRS-961 Verify the qualification, protocol
26.6 qualification, protocol and 2
ANNEXE- and reports for the sterilizers
reports for the sterilizers.
06
Whether the biological indicators
stored and used as per Biological indicators stored and
26.7 Sch-M manufacturer’s instructions. used as per manufacturer’s 2
Whether quality of BI’s checked by instructions
positive controls.
Page 36 of 64
Whether a clear means of It was found clear means of
differentiating ‘sterilized’ from differentiating ‘sterilized’ from
26.8 Sch-M 2
‘unsterilized‘ products is in place.
‘unsterilized‘ products was in
Specify. place
It was found that label on the
basket / tray or other carrier of
Whether the label on the basket /
product / component clearly
tray or other carrier of product /
states:
component clearly states:
● Name of the material
● Name of the material
26.9 Sch-M ● Its batch number 2
● Its batch number
● Its sterilization status
● Its sterilization status
● Indicator (in case it has
● Indicator (in case it has passed
passed through sterilization
through sterilization process)
process)
Whether sterilization records It was found that sterilization

including thermographs and records including thermographs
26.10 Sch-M sterilization monitoring slips and sterilization monitoring slips 2
attached with the Batch attached with the Batch
Production Record. Production Record
27 Sterilization (By Dry Heat)
Whether the sterilization cycle
recording device of suitable size There was in-build facility for
27.1 Sch-M 2
and precision provided in DHS/ sterilization cycle recording.
Tunnel.
As per record produced by the
Whether the position of
firm, the position of temperature
temperature probes used for
probes used for controlling and /
controlling and / or recording
or recording determined during
determined during validation and
27.2 Sch-M validation and (where 2
(where applicable) been checked
applicable) have been checked
against a second independent
against a second independent
temperature probe located in the
temperature probe located in the
same position.
same position.
Whether the chart forms a part of It was found that chart forms a
27.3 Sch-M 2
the batch record. part of the batch record
Whether sterilization cycle
validated only by biological Sterilization cycle validated only
27.4 Sch-M indicator and chemical indicators by biological indicator and 2
or physical validation is also chemical indicators.
carried out.
As per records produced, the
Whether the time allowed reaching
time allowed reaching the
the required temperature before
required temperature before
27.5 Sch-M commencing the measurement of 2
commencing the measurement
sterilizing time, separately
of sterilizing time, separately
determined for each type of load.
determined for each type of load
Page 37 of 64
Are adequate precautions taken to Adequate precautions were
protect the load during cooling taken to protect the load during
27.6 Sch-M after it has gone through the high cooling after it has gone through 2
temperature phase of a heat the high temperature phase of a
sterilization cycle heat sterilization cycle
In case the cooling is affected with
27.7 Sch-M any fluid or gas in contact with the NA NA
product, is it sterilized.
Whether the equipment air inlet It was equipment air inlet and
27.8 Sch-M and outlets been provided with outlets been provided with 2
bacteria retaining filters. bacteria retaining filters
In the process of sterilization by It was found that in the process
dry heat, does the equipment of sterilization by dry heat, does
have: the equipment have:
27.9 Sch-M 1) Air circulation facility within the 1- Air circulation facility within 2
chambers the chambers
2) Positive pressure to prevent 2- Positive pressure to
entry of non-sterile air prevent entry of non-sterile air
WHO
Verify the sterilizer loading pattern Sterilizer loading pattern was
TRS-961
27.10 & whether is complied with the complied with the validated 2
ANNEXE-
validated loading pattern. loading pattern.
06
Whether the process of dry heat
sterilization intended to remove It was found that challenge tests
the pyrogens. using endo-toxine were not
27.1 Sch-M 1
If so, has the validation been done carried out during validation of
with challenge tests using endo- DHS.
toxins.
28. Sterilization (By Moist Heat)
It was found that recording of
Whether recording of both
both temperature and pressure
28.1 Sch-M temperature and pressure carried 2
carried out to monitor the
out to monitor the process.
process.
Whether the control The control instrumentation was
instrumentation independent of independent of the monitoring
28.2 Sch-M 2
the monitoring instrumentation instrumentation and recording
and recording charts. charts
Whether the equipment has
automated control and monitoring The equipment has automated
28.3 Sch-M system, if so, have these been control and monitoring system 2
validated to ensure that critical and found validated
process requirements are met.
Whether the system and cycle The system and cycle faults were
faults are recorded inbuilt and also recorded inbuilt and also
28.4 Sch-M 2
observed by the operator and observed by the operator and
record maintained. record maintained.
Page 38 of 64
Whether the readings of the The readings of the thermograph
thermograph during sterilization during sterilization cycling were
cycling are routinely checked by routinely checked by the operator
28.5 Sch-M 2
the operator against the reading against the reading shown by the
shown by the dial thermometer dial thermometer fitted with
fitted with autoclave. autoclave
Whether the sterilizer fitted with a
drain at the bottom of the chamber The record of temperature at this
If so, does the record of position was recorded throughout
28.6 Sch-M 2
temperature at this position is the sterilizing period.
recorded throughout the sterilizing
period
Are frequent leak tests conducted Frequent leak tests conducted on
28.7 Sch-M on the chamber of the autoclave the chamber of the autoclave on 2
on each day of operation. each day of operation
Whether all items to be sterilized All items to be sterilized (other
28.8 Sch-M (other than sealed containers) are than sealed containers) were 2
wrapped for sterilization. wrapped for sterilization.
Whether the wrapping material
The wrapping material allows
allows removal of air and
removal of air and penetration of
penetration of steam ensuring
28.9 Sch-M steam ensuring contact with the 2
contact with the sterilizing agent at
sterilizing agent at the required
the required temperature for
temperature for required time.
required time
Whether the wrapping prevent The wrapping prevent
28.10 Sch-M 2
contamination after sterilization contamination after sterilization
The steam used for sterilization
Whether the steam used for
was of suitable quality and
sterilization is of suitable quality
doesn’t contain additives at a
and doesn’t contain additives at a
28.1 Sch-M level which could cause 2
level which could cause
contamination of the product or
contamination of the product or
equipment.
equipment.
29. Others:
Specify whether products released
SOP no LP/QA/060-procedure
29.1 Sch-M only after complete filling and 2
for release of batch for dispatch
testing.
Specify whether result of the tests it was found that result of the
relating to sterility, bacterial endo- tests relating to sterility, bacterial
29.2 Sch-M 2
toxins are maintained in the endo-toxins were maintained in
analytical records the analytical records
WHO
Whether process hold time studies As per SOP No- LP/QA-
TRS-961
29.3 has been carried out for various Procedure for Hold Time 2
ANNEXE-
stages of production Studies.
06
30. Documentation and Records
Whether all daily documents are Yes, found filled at the time of
30.1 Sch-M 2
filled correctly and timely. injection
Page 39 of 64
How the documents are designed, The firm has no policy for audit
30.2 Sch-M prepared, reviewed and controlled trail while issuing the 0
to provide an audit trail. documents.
Whether documents are approved
The documents found signed by
30.3 Sch-M signed and dated by appropriate 2
the persons
and authorized person.
Whether documents specify title, Yes documents specified with
30.4 Sch-M 2
nature and purpose. title, nature and purpose
Whether documents are regularly
30.5 Sch-M Yes found reviewed 2
reviewed and kept up to date.
Whether the records are made at
the time of each operation in such
Yes found prepared during
30.6 Sch-M a way that all significant activities 2
inspection
concerning to the production are
traceable.
Whether data is recorded by
electronic data processing system The firm is not having any SOP
or by other means. If by electronic and procedure in place for
30.7 Sch-M 0
data processing system then how preserving the data
access is controlled to enter, electronically.
modify etc. the data.
Whether master formula and At the time of inspection MFR of
30.8 Sch-M detailed operating procedures for Medoxyprogestrone is not found 0
each product are available? prepared.
Specify the duration of retaining
the documents after the expiry of
Sch-M As per SOP LP/QA-025 2
30.9 the respective product and who is
responsible for its maintenance.
Page 40 of 64
Do the manufacturing records pertaining to
manufacture of Sterile & Non- Sterile products
indicate the following details:
Serial number of Batch Manufacturing ,Record
,Name of the product, Reference to Master
Formula Record, Batch/ Lot number, Batch/ Lot
size, Date of commencement and completion of
manufacture, Date of manufacture and
assigned date of expiry, Date of each step in
manufacturing, Names of all ingredients with
reference number given by the quality control
department ,Quantity of all ingredients, Time
and duration of blending, mixing etc. where
ever applicable, PH of solutions whenever
applicable, Filter integrity testing records,
Temperature and humidity records whenever
applicable, Records of plate-counts whenever The BMR of Iron sucrose
applicable, Results of bacterial endo-toxin and Injection Batch No. EHFSI-001,
toxicity, Records of weight or volume of drug M/D 03/2023, E/D 02/2025 was 1
filled in containers, Bio burden records before verified and found incorporated
sterilisation, Leak test records, Inspection all parameters mentioned .
records, Sterilization records including load
details, date, duration, temperature, pressure
etc. Container washing & testing records, Total
number of containers filled, Total number of
containers rejected at each stage, Theoretical
yield, permissible yield, actual yield and
variation thereof, Clarification for variation in
yield ,beyond permissible yield, Reference
number of relevant analytical reports, Details of
re-processing, if any, Names of all operators
carrying out different activities, Environmental
monitoring records, Specimens of different
packaging material, Records of destruction of
rejected containers and packaging material,
and Signature of the competent technical staff
responsible for manufacture and testing.
31 Labels and Other Printed Materials: -
Whether the printing is in bright
31.1 Sch-M colour and legible on labels and Yes found legible 2
other printed materials?
How printed labels (art work) are The firm is having SOP no. QA-
31.2 Sch-M 2
approved. Verify the SOP. 041
WHO Specify whether cut labels or rolled Firm has not produced records of
31.3 1
TRS-986 labels are used. cut labels or rolled labels used.
Page 41 of 64
The firm is having SOP for Art
work approval vide no. LP/QA-
041, however details of Rule 96
and 97 were not mentioned in
details in said SOP.
It was found that the firm was

manufacturing Products i.e. 1-
Gentamicin, Chlorpheniramine
Meleate and Zinc Suplhate Eye
Drops and 2. Ciprofloxacin,
Whether the labels comply with
Chlorpheniramine Meleate and
31.4 Sch-M requirements of Rule 96 & 97 & X
Zinc Suplhate Eye Drops
other relevant provisions
however it was found that using
benzalkonium chloride (BKC) as
preservative in both products.
However, on review of the label
and product carton, no
preservative was mentioned
however Schedule FF of D&C
Rules and IP mentioned that for
Ophthalmic preparation,
preservative should be
mentioned on product label.
32 Master Formula Records: -
How master formula records for The firm is having SOP LP/QA-
32.1 Sch-M each product are prepared, 031 for preparation and control of 2
authorized and controlled. MFR.
Whether master formula is batch The Master formula is not batch
32.2 Sch-M 0
size specific. specific
Whether master formula record
The format includes all
32.3 Sch-M covers all the points as prescribed 2
parametres described inline with
in Schedule ‘M’.
Whether master formula record Master formula record does not
WHO covered all the points as covered all the points as
32.4 0
TRS-986 prescribed in WHO-TRS 986 & prescribed in WHO-TRS 986 &
PIC/S guidelines PIC/S guidelines
33 Batch Processing / Manufacturing Records: -
Whether the BPR/BMR for each
product is prepared on the basis of Yes found as per approved
33.1 Sch-M 2
currently approved master format
formula.
Whether BPR / BMR covered all
33.2 Sch-M the points as prescribed in Yes found covered 2
Schedule ‘M’
Whether BPR / BMR covered all
WHO The firm is not considering the
33.3 the points as prescribed in WHO- 1
TRS-986 same.
TRS 986 & PIC/S
Page 42 of 64
Whether all the documents
Yes found attached for some
33.4 Sch-M generated during Batch production 2
batches
are attached with the BPR /BMR
34 Batch Packaging Records: -
Whether authorized packaging
Yes as per shown the BM & PR
instructions for each product of
34.1 Sch-M of product Iron Sucrose Injection 2
various pack size and type are
Batch no. EHFSI-001
maintained and complied with.
Specify whether all material,
equipment, rooms and packaging
34.2 Sch-M lines are labelled with an indication Yes boards were displayed 2
of product being processed with
batch no.
Whether packaging lines are
The packing lines were found
34.3 Sch-M independent and adequately 2
segregated
segregated.
How line clearance is performed.
Whether records of line clearance The line clearance SOP QA-065
34.4 Sch-M 2
is maintained according to is in place
appropriate checklist.
Do the packaging materials arrive
34.5 Sch-M Cage trolly were found provided 2
on a covered trolley?
Are packaging materials verified
against a master set to ensure that
34.6 Sch-M they are the most recent edition Yes found verified by QA 2
and the correct materials for the
batch?
Are the quantities of packaging
materials verified against the
34.7 Sch-M Yes verified by QA 2
amounts stated as dispensed from
the warehouse?
Specify the monitoring code (bar
WHO
34.8 code, pinholes etc.) for final Not for all products 1
TRS-986
packing materials.
Is the batch yield calculated
immediately upon completion of
Yes the yield is calculated after
34.9 Sch-M packaging operation & prior to the 2
that
introduction of a new batch into the
area?
Is the yield calculation The yield was found calculated
independently verified by second by the production officer and
34.10 Sch-M individual and whether any verified by QA. 2
significant deviation from accepted Till date no deviation is reported
yield is recorded and investigated? as per Deviation log.
Is any excess printed packaging
34.11 Sch-M material destroyed on completion Destroyed after completion 2
of the batch?
Page 43 of 64
Is there a provision in the There was no provision in the
department for the separation of department for the separation of
34.12 Sch-M 0
printed packaging material for printed packaging material for
destruction & rejected product? destruction & rejected product
Whether Batch packaging record
34.13 Sch-M covered all the points as Yes found incorporated 2
prescribed in Schedule ‘M’
Whether Batch packaging record Batch packaging record does
WHO covered all the points as not covered all the points as
34.14 1
TRS-986 prescribed in WHO-TRS 986 & prescribed in WHO-TRS 986 &
PIC/S PIC/S.
Whether all the documents
generated during packaging are
34.15 Sch-M Found attached with some BPRs 2
attached with the Batch packaging
record.
Whether BPR are based on Yes MFR reference no. is
34.16 Sch-M 2
current master formula record. mentioned
35 Standard Operating Procedure and Records: -
Verify the List of SOPs and
The firm is having 547 SOPs in
35.1 Sch-M mention total number of SOPs 2
place
followed by the firm.
35.2 Sch-M Has all the SOPs been displayed. Displayed at various places 2
The formats, logs & SOPs Yes the formats , logs and SOPS
35.3 Sch-M 2
arecurrent were found current
Is any obsolete copy seen in the
35.4 Sch-M No copy of obsolete SOP is seen 2
Area?
36 Reprocessing and Recoveries: -
The firm is having SOP for re-
36.1 Sch-M Verify the SOP for reprocessing. 2
processing No. LP/PT-029
Procedure was in place that
WHO Whether reprocessed batch is
36.2 reprocessed batch is subjected 1
TRS-986 subjected to stability evaluation.
to stability evaluation .
Whether the recoveries are added
36.3 Sch-M into the subsequent batches. If yes No such policy 1
specify the procedures.
37 Finished Product: -
Specify whether finished products Yes the firm is releasing the FG
37.1 Sch-M are held in quarantine until their only after the completion of all 2
final release. testing.
The firm has provided FG store
37.2 Sch-M of finished products after final 2
with appropriate area.
release by QA
38 Quality Control Area: -
Specify whether QC area is Yes the QC Lab is situated in the
38.1 Sch-M 2
independent of production area. second floor of General Block.
The firm has provided chemical,
Specify the working space
38.2 Sch-M instrumental, wet lab and 2
provided for QC:
microbiology laboratory.
Page 44 of 64
approval/rejection of raw
materials, packaging materials, As per pharmasuit electronically
38.3 Sch-M 2
intermediate products and finished controlled
products. Verify the SOP and
record.
Specify the arrangement provided
to protect sensitive electronic Anti-Vibration table not provided
38.4 Sch-L1 1
balances from vibrations, electrical for weighing balances .
interference, humidity etc.
Specify the safety measures taken
Eye shower, goggles , Fire
38.5 Sch-L1 to avoid any accidental hazards in 2
extinguisher were provided.
the QC department.
Specify whether separate washing
Separate area provided for
38.6 Sch-M and drying area is provided for 2
washing and drying.
glassware
Specify which grade of glassware
is used in assay procedures and
whether they are
38.7 Sch-L1 Grade A glassware are used 2
certified/calibrated. Verify the
certificates and calibration
records.
The firm is having outsourced
testing facility agreement:-
A) M/s. Auriga Research Pvt.
Ltd, DC Complex, Opposite
Gianz Hotel, Vill. Bagbania,
Nalagarh, Solan
B) M/s Shree Krishna
Analytical Services Pvt Ltd ,
Specify whether any particular test Mayapuri Industrial Area
is outsourced. If so mention the New Delhi
38.8 Sch-M 1
name of laboratory and verify the C) M/s Oxygen Analytical
contract made in this regard. Laboratories Village Malpur ,
Tehsil BaddiDisttSolan HP
39 Microbiology Lab
Page 45 of 64
The firm has provided only one
AHU in microbiology laboratory
Whether separate AHU's are which caters two rooms includes
39.1 Sch-M provided for microbiological sterility and MLT testing, x
testing areas. however no AHU is provided in
the air locks before entering into
the lab
Whether support areas are under
39.2 Sch-M the same AHU which is used for No AHU in airlock. 0
sterile area.
Briefly describe layout of the The firm has separate entry for
39.3 Sch-M microbiology lab (attach copy of man and dynamic pass box is 1
the layout if available) provided for transfer of material.
Entry to the sterile area was
Whether entry to the sterile area is
through three air lock systems
39.4 Sch-M through three air lock systems with 0
with separate exit however no
separate exit
AHU provided for airlocks.
Specify whether access in sterile
WHO The access in sterile area was
39.5 area is controlled, and if so the 0
TRS-986 not controlled
system followed in this regard
Verify the list of equipment used in
The capacity of incubators is not
the microbiological lab and also
39.6 Sch-M matching with current 1
specify whether these are placed
requirements of incubation.
logically and function accurately
Specify whether operators are
39.7 Sch-M trained in gowning procedures. Training is provided 2
Verify the training records.
Specify the gowning procedure to
Sterile garments were provided
39.8 Sch-L1 enter the sterile area. Verify the 1
by the firm
entry and exit records.
Specify the air class of sterile
Air class of sterility area grade
areas and whether pressure
39.9 Sch-L1 A/B and pressure difference was 2
difference is maintained. Verify the
maintained
records.
Specify whether an environmental
WHO Action and alert limit is prepared
39.10 monitoring programme is followed 2
TRS-986 by the firm
with alert and action limit.
Specify whether a documented
cleaning and disinfection
39.1 Sch-M cleaning and disinfection 2
programme is in place
programme is in place.
Specify whether a procedure for
WHO
39.1 dealing with spillages in sterile Yes SOP is in place 2
TRS-986
area is in place.
Whether separate areas provided
WHO for sterility testing, assay of Two separate rooms were
39.1 2
TRS-986 antibiotics & vitamins and MLT in provided
sterile area.
Specify the type of workstations
39.1 Sch-M Vertical LAF is provided 2
(LAF) provided in the sterile area.
Page 46 of 64
Whether double door autoclave is
provided for transferring of Double door autoclave was not
39.2 Sch-M 1
materials from unclassified area to provided.
sterile area.
The firm is having protocol for the
WHO Verify the area qualification
39.2 same, however no video of air 1
TRS-986 document for sterile area.
pattern is preserved by the firm
Verify the procedure for selection
of sampling location and
interpretation of results for
SOP was prepared however
WHO environmental monitoring of sterile
39.2 physical demarcation was not 1
TRS-986 area along with the SOP and
provided for sample location.
documents. (Specify whether the
method is in compliance with ISO
14644-1).
Specify whether qualification of all
equipment and instruments used All equipments were found
39.2 Sch-L1 2
in this department is covered covered
under VMP.
Verify the qualification document
of major equipment like Re-qualification of incubator was
39.2 Sch-L1 2
autoclave/incubator, hot air oven, found satisfactory carried out.
refrigerator, LAF etc.
Specify the Calibration procedure
of temperature measurement
Yes traceability certificate is in
39.20 Sch-L1 devices used in autoclave and 2
place
incubator. Verify whether it is
traceable to standard temperature.
Verify the procedure for the
39.2 Sch-M handling and disposal of chemical The SOP is in place 2
and microbial waste.
Specify the procedure followed to
WHO
39.2 verify the validity of the test in case Yes it is carried out 2
TRS-986
of antibiotic potency testing.
WHO Specify whether there is separate
39.2 Yes available 2
TRS-986 autoclave for decontamination.
Specify whether the Vendors for
WHO The firm has not approved
39.2 dehydrated media is approved and 1
TRS-986 Vendors for dehydrated media.
qualified.
WHO
Specify whether GPT is carried out The firm has shown the record of
39.3 TRS-986 / 2
for dehydrated media. GPT of dehydrated media
IP
Specify whether performance of
culture media (recovery or survival
The firm has shown the record for
39.3 Sch-L1 maintenance) is carried out and 2
performance of culture media.
the results meet acceptance
criteria.
Page 47 of 64
Specify the source of procurement
The firm has purchased the same
39.3 Sch-L1 of reference culture and its 2
from IMTEC Chandigarh
maintenance.
Specify the Air Grades for
following areas: As the firm has provided only one
—Sterility testing room AHU in the microbiology lab, it is
39.3 Sch-L1 1
—Microbiological Assay room not possible to maintain different
—MLT room Grades with one AHU.
—Airlocks (entry and exit both)
Verify the following records:
—Log book for the entry/exit in the
sterile area The entry exit record is produced
39.3 Sch-M 2
—media preparation record by the firm
—records for water testing (micro)
—records for MLT
Verify how the concentration of the The firm is not having any SOP in
39.30 IP 1
inoculums is determined. this context.
Whether firm has provided
microbiology lab for MLT test for The firm has provided an MLT
39.3 Sch-M 2
non sterile dosage form. If no how test facility.
this test is complied.
40 Quality Control System: -
Specify the source of procurement IPC Ghaziabad and
40.1 Sch-L1 2
of various reference standards Chromachemie Bangalore
The QC has SOP no SOP
LP/QC-004 for storage and
evaluation of reference
standards.
It was found that the QC has no
provision for maintaining uses
reconciliation records of primary
standard and primary standard
was not stored in properly as
primary standard were kept
within leak test apparatus rather
than dedicator. Working
How the reference standards are
40.2 Sch-L1 Standard were stored in amber 0
stored, evaluated and maintained.
vials with rubber stopper which
was sealed with Teflon tape
rather than aluminum seal- for
example- Working standard of
CefiximeTrihydate, WS No- WS-
CEF/50, Fluconazole BP, WS no
– WS-FLU/218 were stored in
amber vials with rubber stopper,
sealed with Teflon tape rather
than aluminum seal and vials
was easily get moisture.
Page 48 of 64
Specify whether authorized
WHO
40.3 access system is followed for No such system is provided. 1
TRS-986
reference standards.
Verify the SOP and records for
As per SOP LP/QC-004.
40.4 Sch-L1 preparation of working standard 1
from the reference standard.
Verify the SOP and records for Firm has provided log book for
40.5 Sch-L1 destruction of unused working consumption of working 1
standard standard.
Verify the sampling SOPs and
SOP ‘ s were checked for
records for:
starting materials
⎯ starting materials
⎯ primary packaging materials
⎯ secondary packaging
materials
materials
⎯ in process materials
40.6 Sch-M ⎯ in process materials 2
⎯ finished products
⎯ water analysis
⎯ water analysis
⎯ wash water analysis
⎯ swab analysis
⎯ swab analysis
⎯ wash water analysis of
⎯ wash water analysis of cleaned
cleaned garments
garments
Specify whether approved
specifications are available for all:
⎯ starting materials
materials
STP ‘s regarding the same are
40.7 Sch-M ⎯ in process materials 2
available with the firm
⎯ water analysis
⎯ swab analysis
⎯ wash water analysis of cleaned
garments
Firm has approved the
specifications on the basis of
AMV in case of in house products
and method verification for
Verify whether all approved pharmacoeial products however
40.8 Sch-L1 specifications are based on Firm has not performed 0
validation. Analytical Method Validation for
Related Substances in case of
Montelukast&LevocetrizineHCl
tablets.
Is there any SOP for handling of

WHO
40.9 OOS product (out of SOP for OOS ie LP/QA-036 2
TRS-986
specification)?
Page 49 of 64
SOP for review of test data
LP/QA-018.
It was found that Raw Material-

Aspartame Power, B no
A2212072P25 was sampled on
25-03-2023 with a total 8
samples and sent to QC for
testing . It was found that
identification was carried out by
FTRI ID No- QCD/FTIR-001 on
27-03-2023, however instead of
WHO Specify the procedure for review of 08 samples, 10 samples were
40.10 0
TRS-986 test data & calculations. run at said Instrument for Raw
Material- Aspartame Power, B no
A2212072P25. One sample run
on 25-03-2023 and another 09
run was carried out on 27-03-
2023, however the QC team has
not produced the IR
Chromatographs for all 10 runs,
only 08 IR Chromatographs of
said material.
Specify whether a designated The firm has not designed a

40.1 Sch-L1 person is responsible for receipt of person responsible for receipt of 1
samples for testing. samples for testing.
40.1 Sch-L1 receiving and recording (logging
in). Verify the SOP and records Procedure for receipt , issuance
2
Specify the procedure for storage and storage SOP LP/QC-005
40.1 Sch-L1 and distribution of received
samples to different analyst.
Page 50 of 64
The firm has not provided
maximum time limit for retention
of sample in the laboratory prior
to testing.
As per Log book for
Bulk/Finished product Analysis
Is there a maximum time limit for
no LP/QC-029/FT-005, QC has
40.1 Sch-L1 retention of sample in the 1
received samples of Norlab-5
laboratory prior to testing?
tabs, B. no- TNORT-001 on 10-
01-2023.
However, till date the sample
was not tested and released the
report.
SOP for preparation,

standardization ie LP/QC-012
preparation, consumption &
40.2 Sch-L1 However firm failed to produce 1
destruction of volumetric solution.
consumption and destruction
Verify the SOP and records.
record of volumetric solution.
It was found that there was a log
Specify whether there is a log book
book for the preparations of the
for the preparations of the reagent
reagent including name of the
40.2 Sch-L1 including name of the analyst, 2
analyst, name of the reagent,
name of the reagent, Calculations,
Calculations, Date of preparation
Date of preparation & expiration.
& expiration
using GR, LR and AR grade of
40.2 Sch-L1 SOP no LP/QC-015 2
chemicals / solvents used for
calibration & sample testing.
Specify whether respective STP is
STP checked randomly and
40.2 Sch-L1 followed by the analyst for 1
found in place
analysis.
Specify the procedure of reporting
Done manually along with raw
40.2 Sch-L1 the result of analysis by the analyst 1
data sheet
to QC Head.
40.20 Sch-L1
storage of samples after testing.
Specify the procedure for retention SOP no LP/QC-066 2
40.2 Sch-L1 of samples after testing is
completed.
40.2 Sch-L1 SOP no LP/QA-029 2
issuance of COA.
Specify procedures for safe
40.2 Sch-L1 removal of waste from the SOP no LP/SOP/QCM-009 2
laboratory.
41 Analytical Method Validation (AMV):-
Page 51 of 64
Specify whether following
Characteristics are considered
during validation of analytical
methods:
⎯ Specificity
Firm has not performed
⎯ Linearity
Analytical Method Validation for
⎯ Range
Related Substances for product-
41.1 IP ⎯ Accuracy 0
Montelukast&LevocetrizineHCl
⎯ Precision
tablets.
⎯ Detection
⎯ Limit
⎯ Quantification
⎯ Limit
⎯ Robustness.
⎯ Solution Stability/Filter Study
42 HPLC Calibration
Verify the records of calibration of
following parameters:
⎯ Calibration of pump. The firm has provided one HPLC
⎯ Calibration of Gradient ID No QCDL/HPLC-001 (Manual
proportionate valve (GPV). Instrument) and it was found that
⎯ Calibration of Auto injector. during its calibration on
42.1 IP ⎯ Calibration of Detector. 15/07/2023, calibration of 1
⎯ Temperature calibration for Gradient proportionate valve
Column oven and (GPV) and Temperature
⎯ Sample Trays compartment. calibration for Column oven not
⎯ Auto Sampler Carry over. carried out.
⎯ Manual injector calibration
⎯ System suitability
43 Dissolution Apparatus Calibration
⎯ Checking of RPM
⎯ Checking of Temperature
⎯ Checking of distance between
inside bottom of the vessel &
paddle
⎯ Checking of distance between
inside bottom of the vessel & It was found that last calibration
43.1 IP Basket was done on 30-10-2022 with 2
⎯ Checking Wobbling of paddle said parameters.
⎯ Checking of Wobbling of
Basket
⎯ Checking of Timer: Calibrate
against standard stop watch
⎯ Performance verification test
[Verify whether dissolution is
calibrated against standard
prednisolone tablets]
Page 52 of 64
44 UV-VIS
⎯ Control of wavelengths
(Wavelength accuracy)
⎯ Control of absorbance
(Photometric accuracy)
⎯ Limit Of Stray Light The firm has not carried out the
⎯ Resolution Power following parameters 1- CELLS
⎯ Resolution (second order Verification 2- I0 flatness during
44.1 IP 1
derivative spectrum) calibration of UV-VIS
⎯ CELLS Verification spectrophotometer dated 06-02-
⎯ I0 flatness 2023.
⎯ Calibration of Visible
Wavelength
⎯ Calibration of absorbance
reproducibility for visible
wavelength
⎯ Photometric linearity at 430nm
46 FTIR
It was found that last calibration
⎯ Verification of the wave
46.1 IP was done on 19-12-2022 with 2
number scale
said parameters.
⎯ Control of resolution
performance
47 TOC Analyzer:
The firm has not installed TOC
47.1 USP ⎯ System suitability: 1
analyzer
⎯ Calibration (Four-point
calibration)
48 Stability Studies
There are 2 stability chambers
Specify whether stability study is
provided one is for conducting
carried out in the QC and if so, is
the real and another is for
there separate area for Stability
conducting accelerated stability
Chamber for stability studies. How
study.
48.1 Sch-M many Stability Chambers have 2
been provided?
Specify whether shelf life of the
Yes, the Self life is assigned on
product is fixed on the basis of
the basis of stability study
stability studies.
conducted by the firm.
Yes. Firm has performed the
WHO Verify the qualification documents
48.2 qualification of the stability 2
TRS-986 of all the stability chambers.
chambers.
Specify whether a written Stability planner for ongoing
WHO
48.3 programme for ongoing stability stability determination 2
TRS-986
determination is in place. maintained
Page 53 of 64
Specify whether a complete
WHO A complete description of
48.4 description of stability study is 2
TRS-986 stability study was available.
available.
Verify the stability calendar along
WHO with stability protocol and Stability calendar and protocol
48.5 1
TRS-986 documents. Attach the copy of were in place.
stability calendar
Specify whether the stability The stability protocol indicates
WHO
48.6 protocol indicates complete set of complete set of testing 2
TRS-986
testing parameters and methods. parameters and methods
Specify whether summary of all Randomly the summary sheet of

WHO
48.7 generated data from the study are stability study of Diclofenac 2
TRS-986
retained. sodium tablets BP bearing batch
no. DORT-001 verified.
For real time/long term study the
frequency of testing schedule
defined in protocol is after
WHO Specify the testing schedule for
48.8 3,6,9,12,24,36 & 48 Months and 1
TRS-986 each product
for accelerated study the
frequency of testing schedule is
3 & 6 months.
Firm has mentioned in their SOP
Specify whether stability study is
no. LP/QA-047 that in case of
WHO performed after any significant
48.9 any change in process 1
TRS-986 changes in process equipment,
equipment, packaging the
packaging materials etc.
stability study will be performed.
WHO Specify the validation method for Temperature and humidity
48.10 2
TRS-986 stability chambers mapping.
Specify the Temperature and
Temperature 30 ±2
WHO humidity for real times studies
48.1 ºC and relative humidity 75 ± 5% 2
TRS-986 carried out for fixing shelf life of
as defined in the protocol.
drug in the country.
49 Quality Assurance: -
Mention the documents prepared
49.1 Sch-M QA has 78 SOP . 2
and maintained by QA department
Specify the responsibility of the QA Firm has SOP for Job
49.2 Sch-M 2
Head. responsibilities LP/QA-028
Specify the procedure followed by
QA department to ensure the Training schedule is provided by
49.3 Sch-M 1
implementation of all SOPs in the QA.
plant.
Verify the total list of SOPs QA has 78 SOP . Firm has an
maintained by QA and how QA issuance and retrieval procedure
49.4 Sch-M 1
ensure that no obsolete SOP is in for ensuring that no obsolete
circulation. SOP is in circulation.
Page 54 of 64
Specify whether any procedure is
Firm is having SOP for
followed for preparation of SOPs
preparation,approval,authorizati
WHO and its circulation to all concerned.
49.5 on,control revision, retrieval and 0
TRS-986 How master, controlled and
destruction of SOP ie LP/QA-
uncontrolled copy of SOPs are
001.
processed.
Firm has SOP for change control
LP/QA-003 ie LPL/CCP-23-001 ;
LP/CCP-23-002;LP/CCP-23-003
however change control no
LP/CCP-23-003 not closed till
date.
Quality Manual System: A)

During the review of change
control log the firm has raised 04
change controls since 01st Jan
2023. The firm is having SOP No.
LP/QA-003 for change control
during review it is found that the
Mention the change control
WHO firm has not fixed the timeline for
49.6 procedures & examine three 0
TRS-986 the closure of change control.
recent change control forms.
Also as per SOP point number
5.4, the indent will be raised by
concerned department to QA.
However as per Change control
number LPL/CCP-23-003
(01.03.2023) for renovation of
capsule section, no indent is
found raised by the concerned
department (production), no
impact analysis was performed
however it was categorized as
minor.
Specify the procedures followed to

Firm has SOP for CAPA LP/QA-
WHO ensure CAPA process. Verify the
49.7 012 and CAPA recorded as per 1
TRS-986 SOP and three recent records in
change control
this regard.
How deviation are controlled.
Verify SOP and three recent SOP for deviation ie LP/QA-004
WHO
49.8 deviations. Specify whether all and no deviation has been taken 1
TRS-986
deviations are reported and on record.
records maintained.
Page 55 of 64
Is the production batch record and
release test results reviewed for
49.9 Sch-M accuracy and completeness
SOP for release LP/QA-029 and
before a batch/lot of finished 2
QA is responsible for release.
product is released?
Verify the checklist and SOP in this
49.10 Sch-M
regard.
Whether QA is involved in control
of starting materials, intermediate
Firm has SOP for Job
49.1 Sch-M products, bulk products, process 2
responsibility of QA LP/QA-028
controls, calibrations, validation
and release of finish goods.
50 Annual Product Quality Review (APQR): -
Specify Whether Annual Product The firm is having APQR SOP
WHO
50.1 Quality review is carried out for no LP/QA-024 but not prepared 1
TRS-986
each product for all produts
Specify whether following criteria
are considered for review:
⎯ Starting materials and
packaging materials
⎯ Critical in-process controls and
finished product results;
⎯ All significant deviations or
non-conformance
⎯ All changes made to the
processes or analytical
methods;
⎯ Results of the stability
WHO In APQR all parameters were
50.2 monitoring programme and 1
TRS-987 found incorporated
any adverse trends
⎯ All quality-related returns,
complaints and recalls and the
investigations performed at the
time
⎯ Adequacy of any other
previous corrective actions on
product process or equipment
⎯ The qualification status of
relevant equipment and utilities
e.g. HVAC, water, or
compressed gases
In the mentioned
Verify whether Cp and CpK values
WHO APQR the calculation of Cp and
50.3 are calculated and what is the 1
TRS-988 CpK is mentioned however
acceptance criteria fixed.
readings were not found
51 Product Recalls: -
Page 56 of 64
The firm has SOP for product
recall however it is ineffective as
51.1 Sch-M Specify the product recall system. 1
no material of NSQ product is
returned backed.
Verify the procedure followed to
51.2 Sch-M No product received back 1
handle the recalled products
Are distribution records available
The distribution record is
51.3 Sch-M for a prompt recall of products from 2
available
the market?
Verify the SOP for recall of
products clearly defining
51.4 Sch-M The firm is having SOP for recall 1
responsibility, procedure
reporting, reconciliation etc.
52 Complaints and Adverse Reactions: -
As per market complaint/ NQS
logbook, it was found that the
firm has received 04 market
complaints/NSQs from last 5
years including Drug Alert for
Product Doxycline and Ambroxol
Capsules, B No- DBQC-004 as
product does not conforms to
claim as per Patent & proprietary
in respect to Assay of
Doxycycline Hydrochloride
calculated as Doxycycline,
Ambroxol Hydrochloride. As per
Are complaints, whether received SOP no LP/QA-016, Procedure
in oral or written form, documented for market recall, it was
52.1 Sch-M 0
in writing, and retained in a mentioned that in case of critical
designated file? health or safety risk, a full recall
shall be initiated. This will
involve contact with wholesalers/
distributors, pharmacist and
medical Practitioners and
possible the consumers. The
firm has initiated the recall of
said Product from market and
only distributor was contacted
for recall. The firm has not
followed the said SOP. It was
found that till date the said
market complaint was not
closed.
Are complaints reviewed on a Complaints reviewed on a
WHO
52.2 timely basis by the Quality timely basis by the Quality 2
TRS-988
Assurance unit? Assurance unit
Page 57 of 64
Is CAPA process followed in
WHO
52.3 response to each complaint Yes as per available SOP 2
TRS-988
documented?
Specify whether system of route
WHO cause analysis is followed by the
52.4 No such information is available 2
TRS-988 firm on the complaint of adverse
drug reaction.
Specify the review system for
The firm is performing review of
52.5 Sch-M complaints concerning the quality 2
complaint
of products.
How records of complaint and
52.6 Sch-M No such complain is received 2
adverse reactions maintained.
Whether the firm has provided
Pharmacovigilance department for
Draft
52.7 analysing complaints of adverse Draft rules under consideration 2
Rules
drugs reactions resulting from the
use of a drug.
Are there any criteria for action to SOP mentioned the recall
52.8 Sch-M be taken on the basis of nature of procedure in as per nature of 1
complaint / adverse reaction? complaints
53 Site Master File: -
The SMF was not factual as the
firm holds valid product
permission for Tablet section
(Beta Lactum) which was not
Whether all the relevant mentioned on SMF. The firm is
53.1 Sch-M information has been included in holding product permission for 0
the site master file. Hormone section and Dusting
powder which is also not
mentioned in SMF. It violates
section 29.1 of Sechdule M of
Drugs and Cosmetics Act 1940
Whether quality policy has been Quality policy was mentioned in
53.2 Sch-M 2
included in the site master file. SMF
Verify whether all information as The other contents of SMF were
53.3 Sch-M 2
per schedule M inline with Schdule M
Verify whether all information as The firm has not incorporated all
WHO
53.4 per WHO TRS 986 and PIC/S information in SMF as per WHO 1
TRS-988
document. TRS and PIC/S document .
54 Validation:
WHO Specify the validation policy of the
54.1 Firm has policy for validation. 2
TRS-988 company
WHO Whether a Validation Master Plan Firm has VMP i.e. LP/VMP/QA-
54.2 2
TRS-988 has been prepared. 002
Verify resources and those QA is responsible for
54.3 Sch-M 2
responsible for its implementation. implementation.
Page 58 of 64
VMP covers requalification of
processes , revalidation of
Identify the systems and equipments, area qualification
WHO
54.4 processes to be validated as per process validation and cleaning 2
TRS-988
VMP validation,analytical method
validation and water system
validation.
Verify whether documentation,
standard operating procedures Firm has prepared separate
WHO (SOPs), Work Instructions and SOP but have incorporated work
54.5 2
TRS-988 Standards (applicable for national instructions,documentation in
and international) are incorporated VMP
in VMP
Validation list for
WHO
54.6 facilities/equipment, processes / Yes, List provided with VMP. 2
TRS-988
procedure and products.
Specify whether key approval
criteria are mentioned in the VMP Objectives are mentioned in the
WHO
54.7 & how record and conclusion of VMP and Validation reports are 1
TRS-988
such validation studies are prepared as per protocol .
prepared and maintained.
Verify Protocol format for each
validation activity, including re- The firm is having SOP for filter
WHO validation and reasonable integrity and recovery, however
54.8 1
TRS-988 unforeseen events (power failures, no policy for system crash is in
system crash and recovery, filter place.
integrity failure.
WHO Whether validation calendar is Validation calender attached
54.9 2
TRS-988 specified in VMP. with VMP.
Specify whether the critical
processes validated Firm is performing process
54.10 Sch-M 1
Prospectively, retrospectively or validation concurrently.
concurrently.
In case electronic data processing
WHO
54.1 systems are used, are these No such procedure 0
TRS-988
validated?
Firm is performing a media fill
Please specify whether periodical challenge test for injections and
WHO
54.1 challenge tests performed on the a visual inspector challenge test 1
TRS-988
system to verify reliability. for qualification of visual
inspector.
Are the validation studies
54.1 Sch-M performed according to pre-
defined protocols? Firm has performed as per
1
Is a written report summarized, protocol
54.1 Sch-M results and conclusions prepared
and maintained?
Page 59 of 64
Is the validity of the critical
WHO processes and procedures
54.2 As per protocol 1
TRS-988 established based on a validation
study?
Are criteria established to assess
WHO
54.2 the changes originating a As per validation plan 1
TRS-988
revalidation?
Trend analysis performed for
water testing, annual product
review.
It was found that the system

Are trend analyses performed to (Computer) used for preparing
assess the need to revalidate in trend analysis of WFI were not
WHO
54.2 order to assure the processes and enabled with login/ID password. 0
TRS-988
procedures continue to obtain the It was found that trend analysis
desired results? of WFI Sample ID no -07, 08, 09
and 10 prepared and saved at
the said system were not
matching with the result
produced by the QC.
55 Internal Quality / GMP Audit Programme:

Does a formal auditing function
55.1 Sch-M exist in the Quality Assurance SOP no. LP/QA-019 was in 2
department? place.
Does a written SOP specify who SOP no. LP/QA-019 in place for
shall conduct audits and conducting the self-inspection
55.2 Sch-M qualifications (education, training, and list of auditors also 2
and experience) for those who maintained. All the HOD are
conduct audits? included.
Does a written SOP specify the
Yes, as per SOP the frequency
scope and frequency of audits and
55.3 Sch-M of audit specified is 6 months for 2
how such audits are to be
all departments.
documented?
Specify whether record is
maintained for CAPA on the basis Yes firm has maintained the
WHO
55.4 of self-quality audit / inspection record for CAPA taken on the 2
TRS-988
and whether same is reviewed by basis of self-quality audit.
the management
56 Pharmaceutical Development:
ICH/Q-8- Whether there is Research and
56.1 No such facility available 2
PICS Development facility available.
Whether formulation development
ICH/Q-8-
56.2 facility up to development of No FND facility available 2
PICS
exhibit batches available.
Whether firm hires consultants for
ICH/Q-8-
56.3 technology transfer. If so, details No consultant is hired 2
PICS
thereof.
Page 60 of 64
Whether firm has adopted latest
ICH/Q-8- No such new product is
56.4 tools (quality by design) to develop 2
PICS developed by the firm
new products.
57 Quality Risk Assessment System: -
Whether the firm has adopted
QRM principle to mitigate risk
involved in pharmaceutical Firm has SOP for quality risk
ICH/Q-9-
57.1 development, manufacturing and management ie LP/QA-042 ,
PICS
distribution. If yes specify which Document number LPL/QA-
2
guidelines are followed in this 042/FT-002 Effective date
regard. 13/01/2023 ,and guideline
Whether firm has policy document mentioned is ICH Q9.
ICH/Q-9-
57.2 on QRM. Specify document
PICS
number and its effective date.
Which known principles have been
ICH/Q-9-
57.3 adopted to analyse risks e.g. FMEA principle was adopted. 2
PICS
FMEA, HAZOP, HACCP, FTA etc.
Whether risk priority number
Firm is calculating RPN number
(RPN) is calculated based on
ICH/Q-9- using severity, occurrence and
57.4 severity, probability and 2
PICS detection and criteria is less than
detectability. If so, what is the
3 for acceptance.
criteria of acceptance.
Tablet process -
How many products, process etc.
ICH/Q-9- compression,packing and visual
57.5 have been analysed for risk. Give 2
PICS liquid injection, Dry injection beta
brief.
category are covered for risk
58 Data Integrity
Page 61 of 64
At the time of visit to the
microbiology lab, it is observed
that the firm has started sterility
testing for below mentioned
products-
1- Amilab 500 mg Inj, Batch No-

ANSI-009, 2- Diclolab Injection,
Batch No- DSSI-054, 3- Ceflox
Eye/Ear Drops, Batch No-
Whether the records are ACSE-005 4. Troxone Inj,Batch
completed at the time of the No- ACFSI-005. Date of analysis
58.1 Sch-M operation and are legible mentioned as 12.04.2023, x
maintained with raw data if
applicable. however no sample of these
products were found charged in
the incubator, which revealed
that the firm was involved in the
generation of fake data for
sterility testing. Other
charged/incubatedsamples were
also examined by the team and
found that no growth even in the
positive samples were observed.
Whether the firm has software-

Firm was using pharmasuit for
58.2 Sch-L1 based manufacturing and testing 2
warehouse and product release
equipment
It was found that OPUS software
used for FTIR instrument and
there were three level of users –
Administrator, Lab Manager and
Whether the individuals are
Default. It was found that
provided log in IDs for access. All
58.3 Sch-L1 common password was 0
login and logout information
maintained for all three users
should be available.
and analysis (Default) was using
right of administrator and Lab
Manager as well.
Whether rights to work, amend,

Firm has SOP for GDP -LP/QA-
58.4 Sch-L1 modify, delete are specified in 1
018
written document.
Page 62 of 64
Whether right to access and
Firm produced SOP for data
modify are with two different
58.5 Sch-L1 Integrity LP/QA-073. 1
individuals. If yes, how QA is
involved in modification of data.
It was found that, in QC, total 04
HPLC (01 Agilent, 02 Shimadzu
and 01 Waters) has been
provided. One HPLC (Waters)
was manual and not having
audit trail facility and date and
time can be changed. It was
found that HPLC data was
saved in E drive and firm has
practice of manual integration
and there was no provision for
back up of HPLC data.
Whether audit trails related to
As per Audit trail of HPLC ID No-
project creation (study creation),
58.6 Sch-L1 HPLC-003, it was found that 0
project (study) modification,
analyst has changed expected
deletion etc. are available.
retention time from 3.91 minutes
to 5.34 minutes on 11-04-2023
at 12.24 AM for product LABDIC
RELIEF TABLETS, B NO-
LRDST-158, the reason for
change of retention time was
mentioned as wedfcwe. The
analyst has not justified the full
form of wedfcwe and
requirement of such change . It
was found that the same
changes was not reviewed by
reviewer/lab manager/QA.
It was found that HPLC data was
Whether the data is backed up at
saved in E drive and firm has
regular intervals. If yes what is the
58.7 Sch-L1 practice of manual integration 1
written back up policy. The data
and there was no provision for
backup must be server based.
back up of HPLC data.
How Excel sheets are validated if The firm has not validated the
58.8 Sch-L1 calculation are done in Excel excel sheet and PC in QC 1
sheet. system.
Whether the firm has QA SOP for Firm has not practice for review
review of data integrity or audit of modification and deletion of
58.9 Sch-L1 0
trail. If yes, how the modification data as part of integrity/audit
and deletions are reviewed. trial.
59 Pharmaceutical Quality Management System (PQS):
Page 63 of 64
Firm has defined the
Specify the management responsibility of management as
WHO
59.1 responsibility defined as per the per quality manual 2
TRS-986
quality manual LP/QM/QA/001 Effective date
31.01.2023.
Specify the Procedures followed
WHO for continual improvement of Firm has SOP for Annual Product
59.2 1
TRS-986 process performance and product Quality Review LP/QA-024.
quality
Specify the performance
indicators presently followed by Firm has SOP for CAPA LP/QA-
the firm to monitor the 012 ,SOP for deviation LP/QA-
WHO
59.3 effectiveness of PQS like product 004 and SOP for Annual Product 1
TRS-986
quality monitoring, CAPA, change Quality Review LP/QA-024.
management and management
review
The firm has included purchase
WHO whether purchases are also
59.4 in PQS vide SOP no.SOP 2
TRS-987 included under PQS
LP/QA-077.
WHO Specify whether life cycle There is no life cycle approach
59.5 1.
TRS-986 approach is followed followed.
Firm has conducted the last
Give synopsis of last to meeting of management on
WHO
59.6 management review meeting held 13.03.2023 related to raw 2
TRS-986
by the firm material store,production and
quality assurance.
Page 64 of 64

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Mfg. Lic. No.

Constitution of the firm

No. of manufacturing blocks

No. of Technical Personnel in

No. of Technical Personnel in QA

No. of Technical Personnel in QC

No. of Technical Personnel from

No. of Technical Personnel in R&D

No. of technical personnel in

No. of Samples drawn by QC (during

No. of Samples declared OOS

No. of samples declared NSQ by

Specify the air handling system

Whether the return air ducts are

Whether the dust collectors are

If yes, pls give a brief account of

The firm was holding the valid

Specify whether disinfectant

1.For product Trimzole DS

2.For product Paracetamol 500

3.For product MicolabTablets ,

Specify whether the filling area is It was found there was no

Whether sterilization records It was found that sterilization

It was found that the firm was

Is there any SOP for handling of

It was found that Raw Material-

Specify whether a designated The firm has not designed a

SOP for preparation,

Specify whether summary of all Randomly the summary sheet of

Quality Manual System: A)

Specify the procedures followed to

It was found that the system

55 Internal Quality / GMP Audit Programme:

1- Amilab 500 mg Inj, Batch No-

Whether the firm has software-

Whether rights to work, amend,

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