Checklist of Self Inspection (Quality Compliance)

Biotechnology Derived Product Facility (Unit-1)

Biotech Division, Incepta Pharmaceuticals Ltd
Version No.: Ref. SOP No.: IPL/BDPF- Approved by:
Doc No.: IPL/BDPF-U1/RF/QA/018 Effective From: Jun, 2014
01 U1/SOP/QA/021 Sign & Date

1. ORGANIZATION & PERSONNEL

# Checklist Yes No N/A
1.1 Is current organizational chart available?

1.2 Are organizational charts in place?

1.3 Have all of the employee’s job description?

1.4 Are all of the employee’s training to perform the routine procedure?

1.5 Is all training record documented? Is individual training card available?

1.6 Are regular and scheduled training courses arranged for personnel?

1.7 Is there any qualified individual act in the absence of the Head of Department?

1.8 Does personnel information recorded for security purpose?

1.9 Are all employees subject to health checks before employment?

Are health examination carried out annually for all the personnel during
1.10
employment?
Are employees reported to supervisory personnel about any health or physical
1.11
condition that may have an adverse effect on drug product safety and purity?
1.12 Are temporary employees given the same orientation as permanent employees?

1.13 Are all employees aware of what to do in the event of fire?

Is there written procedure for accident & incident reporting and handling? Is
1.14
there any incident & accident report form to record accident?
Is there a first aid facility? Are first aid kits easily accessible to each work area,
1.13 with the necessary supplies available? Do employees know first aid/emergency
procedure?
1.14 Are factory employees provided with separate changing and washing facilities?

2. PREMIESIS (Building & Facility)

# Checklist Yes No N/A
Are the doors, windows, walls, ceiling and floor such that no holes or cracks are
2.1 evident (other than those intended by design)?
Are the interior surfaces (walls, floors, and ceilings) smooth, cleanable and easy
2.2 to maintain?
Is there emergency power supply available to take care of entire energy demand
2.3 or at least critical areas?
Does the facility have appropriate controls to maintain required parameters e.g.
2.4 temperature, relative humidity and pressure differentials etc?
2.5 Are there drains that are shallow enough to allow cleaning and disinfection?

2.6 Is there effective lighting and ventilation?

Do light fittings, pipe work, ventilation points and other services installed
2.7 avoiding un-cleanable recesses?
2.8 Do you maintain the documentation room logbook?
 Checklist of Self Inspection (Quality Compliance)
Biotechnology Derived Product Facility (Unit-1)
Biotech Division, Incepta Pharmaceuticals Ltd
Version No.: Ref. SOP No.: IPL/BDPF- Approved by:
Doc No.: IPL/BDPF-U1/RF/QA/018 Effective From: Jun, 2014
01 U1/SOP/QA/021 Sign & Date

2.9 Is the documentation room under lock and keys?

Are all openings, holes, or pipe entries through the outside walls, properly
2.10 sealed or screened?
2.11 Is there adequate dust control where necessary?

3. EQUIPMENT

# Checklist Yes No N/A

3.1 Does IQ, OQ, PQ carried out for all equipment prior to use?

3.2 Have SOP for each equipment and follow the SOP?

3.3 Do you maintain the logbooks for critical equipments?

3.4 Are all of logbooks for equipments updated?

3.5 Are the equipment calibrated on time and according to the scheduled plan?
Are written procedures established for the cleaning and maintaining of
3.6 equipment and utensils?
Has a written schedule been established and is it followed for the maintenance
3.7 and cleaning of equipment?
Are machine surfaces that contact the materials or finished goods non-reactive,
3.8 non-absorptive and non-additive they do not affect the product?
Are designing and operating precautions taken to ensure that lubricants or
3.9 coolants or other operating substances do not come into contact with drug
components or finished product?
Is each idle piece of equipment clearly identified with easily visible marked
3.10 “cleaned; under maintenance” etc.?
3.11 Is idle equipment stored in a designated area?
Are all equipments also marked with an identification number that corresponds
3.12 with an entry in an equipment log?
3.13 Is the maintenance log for each equipment kept on or near the equipment?
Has a sufficiently detailed cleaning and maintenance procedure been written
3.14 for each different equipment to identify any necessary disassembly and
reassembly required to provide cleaning and maintenance?
3.15 Do operators have training on each machine operation?

3.16 Is any change of equipment go through change control?

Have operating limits and tolerances for performance been established from
3.17 performance characteristics?
3.18 Does use safety goggles during welding?
Are sufficient instrument available to calibrate the pressure gauge and air
3.19 velocity meter?
3.20 Do you raise change control during purchasing of new equipments?

4. DOCUMENTATION

# Checklist Yes No N/A

 Checklist of Self Inspection (Quality Compliance)
Biotechnology Derived Product Facility (Unit-1)
Biotech Division, Incepta Pharmaceuticals Ltd
Version No.: Ref. SOP No.: IPL/BDPF- Approved by:
Doc No.: IPL/BDPF-U1/RF/QA/018 Effective From: Jun, 2014
01 U1/SOP/QA/021 Sign & Date

Is there a written procedure describing in sufficient detail for making SOPs (e.g. SOP
4.1
of a SOP)?
Does the written procedure specify the title of the qualified and responsible persons
4.2
who are the authorized signature for approval of SOPs?
4.3 Does each current SOP show the number of the previous SOP that was superseded?
Is the retrieval of superseded SOPs controlled by a responsible person in QA? For how
4.4
long are records retained?
4.5 Do you provide the document number and how can you control?

4.6 Documents distribution and superseded record is updated?

4.7 Is the logbook distribution record updated?

4.8 Is the logbook retrieved record updated?

4.9 Are you achieved the BMR & BPR? How long time achieved?

4.10 Is your documentation fire proof?

4.11 Is your documentation room designed for better traceability?

4.12 Can you show me the design for traceability?

4.13 Do you keep the record of every photocopy of the approved documents?

5. VALIDATION

# Checklist Yes No N/A

Is there a written procedure describing in sufficient detail for writing validation
4.1
protocol?
Is there a validation master plan?

Are all of the equipments incorporated the VMP?

Is the VMP updated?

Are all of the critical equipments performed the IQ, OQ or PQ?

Can you show the list of IQ, OQ & PQ?

Are you performed the risk assessment before IQ, OQ & PQ in case of critical
equipments?
Are you kept the documents about the entrance of new equipments?

Are you kept the record of newly installed IQ, OQ & PQ status?
Does the written procedure specify the title of the qualified and responsible persons
4.2
who are the authorized signature for approval of SOPs?
4.3 Does each current SOP show the number of the previous SOP that was superseded?
Is the retrieval of superseded SOPs controlled by a responsible person in QA? For how
4.4
long are records retained?
4.5 Do you provide the document number and how can you control?

4.6 Documents distribution and superseded record is updated?

 Checklist of Self Inspection (Quality Compliance)
Biotechnology Derived Product Facility (Unit-1)
Biotech Division, Incepta Pharmaceuticals Ltd
Version No.: Ref. SOP No.: IPL/BDPF- Approved by:
Doc No.: IPL/BDPF-U1/RF/QA/018 Effective From: Jun, 2014
01 U1/SOP/QA/021 Sign & Date

4.7 Is the logbook distribution record updated?

4.8 Is the logbook retrieved record updated?

4.9 Are you achieved the BMR & BPR? How long time achieved?

4.10 Is your documentation fire proof?

4.11 Is your documentation room designed for better traceability?

4.12 Can you show me the design for traceability?

4.13 Do you keep the record of every photocopy of the approved documents?

6. ENVIRONMENTAL MONITORING

# Checklist Yes No N/A

Is there an environmental monitoring program for the aseptic batch manufacturing
5.1
area, sterile filling room, sterile filling line and ancillary areas?
Is schedule for microbiological environmental testing indicated in SOP? Is frequency of
5.2
environment monitoring performing as per respective SOP?
5.3 Is environmental monitoring equipment on a maintenance / calibration program?

5.4 Is non viable particulate sampling performed?(particle count)?

5.5 Is surface sampling performed? (e.g. Swab test/Contact plate)?

Is settle plate testing conducted at each working shift? Which media is used? What is
5.6
the exposure time?
5.7 At what temperature for how long are environmental monitoring samples incubated?
Are there standardized and validated autoclave loads for nutrient media used for
5.8
environmental monitoring?
5.9 Does personnel hygiene checked regularly and record retrained?
Is physical parameter (temperature, humidity, pressure differential) of sterile area
5.10
check daily/regularly?
Is control of air pressure, dust, particulate, humidity and temperature adequate for the
5.11
manufacture, processing, storage or testing of drug products?
5.12 Is environment and hygiene monitoring record sheet properly documented?

5.13 Is failure investigation conducted in case of OOS and record retained?

Are waste disposal facilities available in factory (e. g ETP/Incinerator)? Is waste
5.14
separated for recycling where possible?
5.15 Does this facility have written procedure for waste disposable?
Is log sheet maintained at every time when ETP plant operates? What are the chemical
5.16
used for effluent treatment? (Caustic soda /Polyelectrolyte/Ferrous Sulphate)?