SCHEDULE M

JIJO THOMAS
M.PHARM PHARMACEUTICS
COLLEGE OF PHARMACEUTICAL
SCIENCES
TRIVANDRUM
CONTENTS
 Introduction
 Schedule M
 Part I
 Part II
 Schedule M I
 Schedule M II
 Schedule M III
INTRODUCTION
 GMP is that part of Quality assurance which ensures that
the products are consistently manufactured and
controlled to the Quality standards appropriate to their
intended use.
 "GMP" - A set of principles and procedures which, when
followed by manufacturers for therapeutic goods, helps
ensure that the products manufactured will have the
required quality
US FDA GMP Regulation :
 Section 21 of the CFR contains most regulations pertaining
to food and drugs
21 Code of Federal Regulations Part 210:
Current Good Manufacturing Practice in Manufacturing
Processing, packing, or Holding of Drugs.
21 Code of Federal Regulations Part 211:  Current Good
Manufacturing Practice for Finished Pharmaceuticals.

ICH GMP Regulation:

Q7 /Q&As Q7: Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients
GMP REGULATIONS IN
INDIA
• GMP regulations were introduced in the form of
amended schedule M in 1988.
• Again amended by Drug & Cosmetics Rules 2001
and embraces rules 71,74,76&78 under the D&C
rules 1945
• Each licensee shall evolve appropriate methodology
systems and procedures, which shall be
documented and maintained for inspection and
reference.
• The manufacturing premises shall be used
exclusively for production of drugs and not for any
other manufacturing.
SCHEDULE M
PART -1
GMP for premises & materials

• Specific requirements for manufacture of sterile

Part 1A products, parenteral preparations, & sterile
ophthalmic preparation

Part 1B • Specific requirements for manufacture of oral solid

dosage forms

Part 1C • Specific requirements for manufacture of oral

liquids

Part 1D • Specific requirements for manufacture of topical

preparations

Part 1E • Specific requirements for manufacture of metered

dose inhalers(MDI)

Part 1F • Specific requirements for manufacture of active

pharmaceutical ingredients
1. GENERAL REQUIREMENTS

1.1 . Location and surroundings:

The factory building(s) for manufacture of drugs shall
be so situated that it avoid risk of contamination from
external environmental including open sewage, drain,
public lavatory
1.2. Building and premises :
• Buildings shall be designed, constructed, adapted
and maintained to permit production of drugs under
hygienic conditions
• They shall conform to the conditions laid down in the
Factories Act, 1948
The premises used for manufacturing, processing,
warehousing, packaging, labeling and testing purposes
shall be
i. compatible with other drug manufacturing
operations
ii. adequate working space to avoid the risk of mix-up
between different materials & avoid the possibilities
of contamination and cross contamination
iii. designed / constructed / maintained to prevent
entry of insects, pests, birds, and rodents
iv. Well illuminated, effectively ventilated, with proper
Air Handling Units
1.3 Water System:
• There shall be validated system for treatment of water in
accordance with standards specified by the Bureau of
Indian Standards or Local Municipality or Pharmacopoeial
specification

• Water shall be stored in tanks, which do not adversely

affect quality of water and ensure freedom from
microbiological growth

• The tank shall be cleaned periodically and records

maintained by the licensee in this behalf
1.4. Disposal of waste
• The disposal of sewage and effluents (solid, liquid and gas) be
in conformity with the requirements of Environment Pollution
Control Board

• All bio-medical waste shall be destroyed as per the provisions of

the Bio-Medical Waste (Management and Handling) Rules,
1996

• Records shall be maintained for all disposal of waste

• Provisions shall be made for the proper and safe storage of

waste materials awaiting disposal
2. WAREHOUSING AREA 
2.1 Adequate areas to allow orderly warehousing of various
categories of materials.
2.2 Good storage conditions
2.3 There shall be a separate sampling for active raw
materials and excipients
2.4. Segregation shall be provided for the storage of
rejected, recalled or returned materials or products
2.5 Highly hazardous, poisonous and explosive materials
shall be stored in safe and secure areas
3. PRODUCTION AREA

3.1. Separate dedicated and self-contained facilities shall be

made available for the production of sensitive
pharmaceutical products
3.2. Orderly and logical positioning of equipment and
materials and movement of personnel to minimize risk of
omission or wrong application of any manufacturing and
control measures
3.3. Services lines shall preferably be identified by colours
and the nature of the supply and direction of the flow shall
be marked/indicated
4. ANCILLARY AREAS

4.1 Rest and refreshment rooms shall be separate

from other areas.
Facilities for changing, storing clothes and for washing
and toilet purposes shall be adequate for the number
of users.
4.2 Animal houses shall be those as prescribed in
Rule 150-C(3) of the Drugs and Cosmetics Rules,
1945 which shall be adopted for production purposes.
5. QUALITY CONTROL
AREA.
5.1. QC Lab shall be independent of the production
areas. Separate areas each for physico-chemical,
biological, microbiological or radio-isotope analysis

5.2 Adequate space shall be provided to avoid mix-ups

and proper storage for test samples, retained samples,
reference standards, reagents and records.
6. PERSONNEL

6.1. Qualifications and practical experience in the

relevant field
6.2. Written duties of technical and Quality Control
personnel shall be laid and follow strictly
6.3. Number of personnel employed shall be adequate
and in direct proportion to the workload
7. HEALTH, CLOTHING AND
SANITATION OF WORKERS
7.1 Prior to employment, all personnel, shall undergo
medical examination and a periodically examination is
carried out, records are also maintained
7.2 Proper training shall be given to all employees to
maintain personnel hygiene and adequate facilities for
personal cleanliness
7.3 Smoking, eating, drinking, chewing , food, drink
and personal medicines not permitted in production,
laboratory, storage area
8. MANUFACTURING
OPERATIONS AND CONTROLS
8.1 All manufacturing operations shall be carried out
under the supervision of technical staff approved by
the Licensing Authority
8.2. Precautions against mix-up and cross-
contamination-
1. By proper air handling system, pressure
differential, segregation, status labelling and
cleaning. Proper records and SOP there of shall
be maintained.
2. Processing of sensitive drugs and cytotoxic
substances in segregated areas
3. Proper labeling of materials and equipments
4. Packaging lines shall be independent and adequately
segregated
5. All printing and overprinting shall be authorized in
writing
6. The manufacturing environment maintained at the
required levels of temperature, humidity and
cleanliness
9. SANITATION IN THE
MANUFACTURING PREMISES
9.1 The manufacturing premises shall be cleaned and in an
orderly manner
9.2 The manufacturing areas shall not be used for other
operations
9.3 A routine sanitation program shall be drawn up which
shall be properly recorded and which indicate–
a) specific areas to be cleaned and cleaning intervals
b) cleaning procedure to be followed
c) personnel assigned to and responsible for the
cleaning operation.
10. RAW MATERIALS
10.1 Keeping an inventory of all raw materials to be
used and maintain records as per Schedule U
10.2 Authorized staff who examine each consignment
for its integrity
10.3 Labeling with the following information:
a) Name of the product and the internal code
reference and analytical reference number
b) Manufacturer’s name, address and batch number
c. The status of the contents (e.g. Quarantine,
under test, released, approved, rejected)
d. The manufacturing date, expiry date and re-
test date.
11. EQUIPMENT
11.1 Equipment shall be located, designed, constructed,
adapted to suit the operations and log book is maintained
11.2 Equipment shall be calibrated and checked on a
scheduled basis in accordance to SOP and maintain
records
11.3 Equipment shall be inert and defective are removed
and labeled
12. DOCUMENTATION
AND RECORDS

Documentation is an essential part of the Quality

assurance system and Its aim is to define the
specifications for all materials, method of manufacture
and control to release a batch of drug for sale
12.1 Documents shall be approved, signed and dated by
authorized persons
12.2 Documents shall specify : the title, nature and
purpose laid out in an orderly fashion & kept up to date
12.3 SOP shall be retained for at least one year after the
expiry date of the finished product
12.3 Data may be recorded by electronic data processing
systems but Master Formulae and detailed operating
procedures relating to the system in use shall also be
available in a hard copy to facilitate checking of the
accuracy of the records
 13. LABELS AND OTHER
PRINTED MATERIALS
• Labels are necessary for identification of the drugs and their
use. The Printing shall be done in bright colours and in a
legible manner
• The label shall carry all the prescribed details about the
product
13.1 All containers and equipment shall bear appropriate
labels
13.2 Prior to release, all labels for containers shall be
examined by the QC Department
13.3 Records of receipt of all labeling and packaging materials
shall be maintained and unused coded, damaged labels and
packaging materials shall be destroyed and recorded.
14. QUALITY ASSURANCE
It is a wide-ranging concept concerning all matters that
individually or collectively influence the quality of a product
It shall ensure that: -
• The pharmaceutical products are designed and
developed in a way that takes account of the
requirement of GMP ,GLP and GCP
• Adequate controls on starting materials, intermediate
products, and other in-process controls, calibrations,
and validations are carried out
• Products are released after authorized persons have
certified
 15. SELF INSPECTION AND
QUALITY AUDIT
It is for the assessment of all or part of a system with the
specific purpose of improving it
15.1 The program is designed to detect shortcomings in the
implementation of GMP and to recommend the necessary
corrective actions.
• Self-inspections shall be performed routinely and on specific
occasions
• The team responsible for self-inspection shall consist of
independent, experienced, qualified persons from within or
outside the company who can evaluate the implementation
of GMP objectively; all recommendations for corrective
action shall be implemented.
15.2 The procedure for self-inspection shall be
documented indicating self-inspection results; evaluation,
conclusions and recommended corrective actions with
effective follow up program.

16. QUALITY
CONTROL SYSTEM
• Quality control shall be concerned with sampling,
specifications, testing, documentation, release
procedures
• Materials are not released for use, nor products
released for sale or supply until their quality has
been judged to be satisfactory
16.1 QC lab should have qualified and experience staff
16.2 QC lab may be divided into Chemical, Instrumentation,
Microbiological and Biological testing
16.3 The QC department shall conduct stability studies of
the products to ensure and assign their shelf life. All records
of such studies shall be maintained
16.4 All instruments shall be calibrated and validated before
adopted for routine testing
16.5 Pharmacopoeia, reference standards, working
standards, references spectra, other reference materials
and technical books, as required, shall be available in the
QC Laboratory
17. SPECIFICATION
17.1 For raw materials and packaging materials
They shall include:
a) The designated name and internal code reference
b) Reference, if any, to a pharmacopoeial monograph
c) Qualitative and quantitative requirements with acceptance
limits
d) Name and address of manufacturer or supplier and original
manufacturer of the material
e) Specimen of printed material
f) Directions for sampling and testing or reference to
procedures
g) Storage conditions and
h) Maximum period of storage before re-testing
17.2 For finished products. Appropriate specifications for
finished products shall include:
a) The designated name of the product and the code
reference
b) The formula or a reference to the formula and the
pharmacopoeial reference
c) Directions for sampling and testing or a reference to
procedures
d) A description of the dosage form and package details
e) The storage conditions and precautions, where
applicable
f) The shelf-life
18. MASTER FORMULA RECORDS
• There shall be Master Formula records relating to all
manufacturing procedures for each product and batch
size
• These shall be prepared and endorsed by head of
production and quality control
• The master Formula shall include:
a) the name of the product together with product
reference code relating to its specifications
b) the patent or proprietary name of the product along
with the generic name, a description of the dosage
form, strength, composition of the product and batch
size
c) name, quantity, and reference number of all the
starting materials to be used
d. A statement of the processing location and the
principal equipment to be used
e. detailed stepwise processing instructions and the
time taken for each step
f. the instructions for in-process control with their
limits
g. the requirements for storage conditions of the
products, including the container, labeling and
special storage conditions where applicable
h. any special precautions to be observed and
i. packing details and specimen labels
19. PACKING RECORDS
There shall be authorised packaging instructions for each
product, pack size and type
These shall include or have a reference to the following:
a) Name of the product
b) Description of the dosage form, strength and composition
c) The pack size expressed in terms of the number of
doses, weight or volume of the product in the final
container
d) Special precautions to be observed, including a careful
examination of the area and equipment in order to
ascertain the line clearance before the operations begin.
 20. BATCH PACKAGING RECORDS
• A batch packaging record shall be kept for each batch or
part batch processed
• It shall be based on the relevant parts of the packaging
instructions, and the method of preparation of such records
shall be designed to avoid transcription errors

21. BATCH PROCESSING RECORDS

• There shall be Batch Processing Record for each product
• It shall be based on the relevant parts of the currently
approved Master Formula
• The method of preparation of such records included in the
Master Formula shall be designed to avoid transcription
errors
22. STANDARD OPERATING
PROCEDURES (SOPs)
There shall be written SOP and records for the :
• Receipt of each delivery of raw, primary and printed material
• Internal labeling, quarantine and storage of starting materials,
packaging materials and other materials, as appropriate
• For each instrument and equipment
• Sampling which include the person(s) authorized to take the
samples
• Describing the details of the batch numbering which ensure
that each batch of intermediate, bulk or finished product is
identified with a specific batch number
• Testing materials and products at different stages of
manufacture, describing the methods and equipment to be
used
23. REFERENCE SAMPLES
23.1 Each lot of every active ingredient, in a quality
sufficient to carryout all the tests, except sterility and
pyrogens / Bacterial Endotoxin Test, shall be retained for a
period of 3 months after the date of expiry of the last batch
produced from that active ingredient
23.2. Samples of finished formulations shall be stored in
the same or simulated containers in which the drug has
been actually marketed
24. REPROCESSING AND
RECOVERIES:
• Where reprocessing is necessary, written procedures
shall be established & approved by quality assurance
department
• Recovery of product residue may be carried out , if
permitted, in the master production

25.DISTRIBUTION RECORDS:
Records of distribution shall be maintained in a manner
such that finished batch of a drug can be traced to the
retain level to facilitate prompt and complete recall of the
batch, if and when necessary
26. VALIDATION AND PROCESS
VALIDATION:
• The process employed has been optimized , so that data
generated may be considered credible & evaluated for
consistency as well as relevance
• Validation studies shall conducted as per the pre-defined
protocols
• These shall include validation of processing, testing and
cleaning procedures
27. PRODUCT RECALLS:
• A prompt and effective product recall system of defective
products shall be devised for timely information of all
concerned stockiest, wholesalers, suppliers, up to the
retail level within the shortest period
• The licensee may make use of both print and electronic
media in this regard
28. COMPLAINTS AND
ADVERSE REACTIONS:
• All complaints thereof concerning product quality
shall be carefully reviewed and recorded according
to written procedures
• Reports of serious adverse drug reactions resulting
from the use of a drug along with comments and
documents shall be reported to the concerned
licensing authority
29. SITE MASTER FILE:
• It contains specific and factual GMP about the production
and/or control of pharmaceutical manufacturing preparations
carried out in the licensed premises
• It shall contain the following:-
 General Information
 Personnel
 Premises
 Equipment
 Sanitation
 Documentation
 Production
 Quality Control
 Loan license manufacture and License
 Distribution, Complaints and Product recall
 Self Inspection & Export of Drugs
 PART 1A: sterile products

• General :
 Sterile products being very critical & sensitive in
nature, a high degree of precautions, prevention &
preparations are needed
 Prescribed standards for supply of water, air, active
materials, maintenance of hygienic conditions
• Buildings and civil works:
 Built of standardized material to avoid cracks in critical
areas
 Manufacturing area clearly separated into support
areas, preparation areas, change areas and aseptic
areas
 Aseptic area:
 Walls, floors and ceilings should be impervious, non-
shedding & non-cracking
 Walls shall be flat & ledges and recesses can be avoided
 Ceilings shall be solid & joints shall be sealed
 No sinks & drains in grade A & grade B areas
 Doors made of aluminum or steel material & shall open
towards high pressure area
 Separate exit space from the aseptic areas is advisable
 Change rooms to aseptic areas shall be clearly
demarcated into black, grey & white rooms
• Air handling system:
 Critical areas conforming to grade B,C & D have separate
air handling units

Grade Class Operations

Grade A Class 100 Aseptic preparation&
filling
Grade B Class 1000 Background room
conditions for
activities requiring
grade A
Grade C Class 10000 Preparation of solution
to be filtered
Grade D Class 100000 Handling of
components after
washing
• Environment monitoring:
Recommended periodic monitoring include:
Particulate monitoring in air - 6 monthly
HEPA filter integrity testing – yearly
Air change rates – 6 monthly
Air pressure differentials – daily
Temperature & humidity – daily
Microbiological monitoring – daily
• Garments:
Made of non-shedding & tight weave material
Outdoor clothing shall not be brought into sterile areas
• Sanitation:
Employees carrying out sanitation shall be trained
Different sanitizing agents used in rotation
Records of rotational use these agents to be maintained
 • Include component washing machines,
steam sterilizers, membrane filters, liquid
Equipment & powder filling machine , sealing &
labelling machines etc

• Potable water – microbiological

specification(<500cfu/ml) &
• Absence of individual pathogens per
Water and 100ml used for preparation of purified
water
steam system • Steam coming in contact with products
primary containers shall be sterile &
pyrogen free
• Bulk raw materials monitored for bio-
burden periodically
Manufacturing • A limit of not more than 100cfu/ml is
process recommended
• Finished products shall be filled in
continuous operation with great care
 • Terminal sterilization(filling of products) - grade A
• Preparation of solution(sterilized by filtration) -
grade C
• Sterilization process should be validated
Sterilization • Biological/ chemical indicators – to monitor
sterilization

• Records related to manufacture of products

should be maintained

Documentation
 PART 1B: oral solid
dosage forms

• General requirements:
 Enclosed dust control manufacturing system shall be
employed
 Suitable environmental conditions maintained by installation
of air- conditioning
 Effective air-extraction system shall be provided with
discharge
 Filters to retain dust to protect the local environment
• Sifting, mixing & granulation:
 All equipments shall be fitted with dust extractors
 Critical operating parameters like time &temperature shall be
specified in master formula
 Monitored during processing & recorded in batch records
 Granulation & coating solution- made, stored & used in a
manner to minimize contamination
 Tablet compression:
 Compressing machine – effective dust control facilities
 Suitable labelling to prevent mix up of granules & tablets
on compression machinery
 Tablets examined for appearance, wt. variation,
disintegration, hardness, friability & thickness
 Tablet coating:
 Air provided with suitable exhaust system & environmental
control
 Air supplied to coating pans shall be filtered & of suitable
quantity
Filling of hard gelatin capsules
• Stored in conditions which ensure safety from effects of
excessive heat & moisture

Printing(tablets & Capsules)

• Special care must be taken to avoid product mix-up during
printing
• Done using edible colors & suitable printing ink

Packaging
• Before packaging operation all ‘rogue’ tablets & capsules are
removed
• Strips - inspected for defects such as misprint, cut on foil,
missing tablets & improper sealing
 PART 1C : oral
liquid dosage
forms

 Layout & design of manufacturing area – minimize

risk of contamination & mix-up
 Manufacturing area – entry through double door air-
lock facility
 Parts of equipment – made of stainless steel
 Quality of purified water used shall be specified &
monitored routinely
 Manufacturing personnel shall wear non- shedding
clothing
 Primary packaging area – air supply filtered through
5 micron filters & temperature not exceed 30ºC
 PART 1D : topical
preparations

 Suitable air-lock shall be provided at the entrance

 Manufacturing area – air shall be filtered & air
conditioned
 These areas to be fitted with exhaust systems
 Equipments designed to prevent product
contamination
 For cleaning or drying no rags or clusters to be used
 Water used in compounding – Purified Water IP
 Powders used must be properly sieved
 Separate packaging section – for primary packaging
 PART 1E : MDIs

General:
Manufacture of MDI - minimum microbial & particulate contamination
Building & civil works:
Located on a solid foundation to reduce risk of cracking walls &
floors
Environmental condition:
Where products or clean components are exposed, the area
shall be supplied with filtered air of grade C
Equipment:
Manufacturing equipment – closed system where vessels & supply
lines are stainless steel
Manufacture:
Approved master formula records are required for
manufacture of MDI
Primary packaging material – cleaned by compressed air
filtered through 0.2 micron filter
Filled containers shall be quarantined for a suitable period
to detect leaking containers

Documentation :
Temperature & humidity in the manufacturing area
Periodic filled weights of formulation
Records of rejections
 PART 1F : APIs

Buildings & civil works:

 Manufacture of antibiotics, steroids & cytotoxic
substances – carried out in confined areas to prevent
contamination of other manufactured drugs
 Air filtration system – includes pre-filters & particulate
matter retention air filters
Sterile products:
 Filling of such products must be done aseptically
 Manufacture of sterile API must include- filtration,
crystallization & lyophilization
Utilities / Services:
 Equipments used – serviced, cleaned & maintained at
appropriate intervals
 So as to prevent mal- function or contamination of drug
product
Equipment design, size & location:
 Equipment used in manufacture, processing, packaging
or holding of API shall be adequate size, appropriate
design &
 Suitably located to facilitate operations for its intended
use & for its cleaning & maintenance
 Equipments - cleaned between successive batches
In- process control:
For chemical reactions include:
Reaction time
Reaction mass appearance
Reaction temperature
Concentration of reactant
Assay or purity of the product
For physical operations include:
Appearance & color
Uniformity of blend
Temperature of a process
Concentration of solution
Processing rate or time
Product containers & closures:
• Should comply with pharmacopoeial specification
• Containers & closures shall be non-reactive, additive,
adsorptive or leachable
• To an extent that affects quality or purity of the drug
 PART II

External preparation:
Basic installation area: 30sq.m
Ancillary area: 10sq.m
Equipments include:
• Mixing & storage tank(stainless steel)
• Jacketed kettle(stainless container)
• Mixer
• A colloidal mill or suitable emulsifier
• A triple roller mill
• Liquid filling equipment
• Tube filling equipment
Oral liquid preparation:
Basic installation area:30sq.m
Ancillary area:10sq.m
Equipments include:
• Mixing & storage tanks
• Jacketed kettle
• Portable stirrer
• A colloidal mill
• Filtration equipment
• Semi automatic filling machine
• Pilfer proof cap sealing machine
• Water distillation unit deionizer
• Clarity testing inspection unit
Tablets:
Basic installation area :60sq.m(uncoated)
30sq.m(coated)
Ancillary area :20sq.m(uncoated)
10sq.m(coated)
Tablet production department classified into four
sections:
Mixing,
Mixing, Tablet
Tablet
granulatio
granulatio compress
compress
nn &
& drying
drying ion
ion
section
section section
section

Coating
Coating
Packagin
Packagin section
section
gg section
section (wherever
(wherever
required)
required)
Mixing, granulation & drying section:
• Disintegrator & sifter
• Powder mixer
• Granulator wherever required
• Thermostatically controlled hot air oven
• Weighing machines
Compression section:
• Tablet compression machine
• Punch & die storage cabinets
• Tablet de-duster
• Tablet inspection unit
• Dissolution test apparatus
• In-process testing apparatus
• Air conditioning & dehumidifier
Packaging section:
• Strip /blister packaging machine
• Leak test apparatus
• Tablet counters
• Air-conditioner & dehumidifier
Coating section:
• Jacketed kettle
• Coating pan
• Polishing pan
• Exhaust system
• Air conditioner & dehumidifier
• Weighing balance
Powders:
Basic installation area: 30sq.m
Equipments include:
• Disintegrator
• Mixer (electrically operated)
• Sifter
• Stainless steel vessels
• Filling equipment
Capsules:
Basic installation area: 25sq.m
Ancillary area:10sq.m
Equipments include:
• Mixing & blending equipment
• Capsule filling unit
• Capsule counters &
• Polishing equipment
Surgical dressing:
Basic installation area:30sq.m
Equipments include:
• Rolling & trimming machine
• Cutting equipment
• Folding & pressing machine for gauze
• Mixing tanks for processing medicated dressing
• Hot air dry oven
• Steam or dry heat sterilizer
Ophthalmic preparations :
Basic installation area : 25sq.m
Equipments include:
• Hot air oven
• Kettle
• Colloidal mill
• Tube filling equipment
 • Mixing & storage tanks
• Seitz filter or sintered glass filters
• Liquid filling equipment
• Autoclaves
Pessaries & suppositories:
 Basic installation area:20sq.m
 Equipments include:
• Mixing & pouring equipment
• Molding equipment
• Weighing devices
 Inhalers :
 Basic installation area: 20sq.m
 Equipments include:
• Mixing equipment
• Graduated delivery equipment
• Sealing equipment of medicament during filling
Repacking of drugs & pharmaceutical chemicals:
Basic installation area: 30sq.m
Equipments include:
• Sifter
• Stainless steel vessels
• Weighing & measuring equipment
• Filling equipment
• Electrical sealing machine
Parenteral preparation:
Basic installation area: 60sq.m(partitioned into
suitable sized cubicles with air lock arrangement)

Process of manufacture divided into:

Preparation of containers & closures
Preparation of solution
Filling & sealing
Sterilization & testing

Equipments include:
Manufacturing area:
• Storage equipment
• Washing & drying equipment
• Dust proof storage cabinet
• Water still
• Preparation & mixing tanks and equipments
• Filtering equipment
• Hot air sterilizer

Aseptic filling & sealing room:

• Benches for filling & sealing
• Bacteriological filters
• Filling & sealing unit under laminar flow

General room:
• Inspection table
• Leak testing equipment
• Labelling & packaging unit
• Storage equipment including cold storage & refrigeration
SCHEDULE M-I Requirements of factory
premises of homoeopathic preparations
1. General Requirements: Location and Surroundings;
Buildings; Water supply Health, Clothing and Sanitation
of Workers; Medical Services, container management
etc. comes under this.
2. Requirements of Plant and Equipment:
a) Mother tinctures and Mother solution Section- An
area of 55 sq. meters is recommended for basic
installations
b) Potentisation Section- Method of potentisation will
be adopted as specified in Homoeopathic
Pharmacopoeia of India Vol.I
 SCHEDULE M-II : Requirement of premises for
manufacture of cosmetics
• General Requirements: Location and Surroundings; Buildings; Water
supply; Health, Clothing and Sanitation of Workers; Medical Services etc
• Requirements of Plant and Equipment: Specifications are given for
only certain cosmetic preparations like
a) Powers
b) Creams, lotions, emulsions, pastes, cleansing milks, shampoos,
pomade, brilliantine, shaving creams, and hair-oils etc
c) Nail Polishes and Nail lacquers
d) Lipsticks and lip-gloss
e) Depilatories
f) Preparations used for Eyes
g) Aerosol
h) Alcoholic Fragrance Solutions
i) Hair Dyes
j) Toilet Soaps
k) Tooth powders and toothpastes
SCHEDULE M-III Requirements of factory
premises for manufacture of medical
devices
General Requirements: Location and Surroundings; Buildings;
Water supply; Health, Clothing and Sanitation of Workers; Medical
Services etc comes under this
Requirements for Manufacture Of Medical Devices: Shall be
conducted bat the licensed premises, and the process of
manufacture is divided into following separate
operations/Sections-
a) Moulding
b) Assembling
c) Raw Materials
d) Storage Area
e) Washing, drying and sealing area
f) Sterilization
g) Testing facilities
cGMP

• What is cGMP ? : Usually see “cGMP” – where c =

current, to emphasize that the expectations are
dynamic 
• In India it is established in 2000 & amended from
July 2004
• It is periodically reversed and updated
 CONCLUSION
• GMP is an important tool in quality control of
drug products
• Legal regulation of GMP is important to control
the quality of drugs manufactured with in the
country
REFERENCES
1. Manual on Drugs and Cosmetics; sixth edition; 2009
2. Schedule M: Good Manufacturing Practices And Requirements
Of Premises, Plant And Equipment For Pharmaceutical Products.
Gazette Of India Extraordinary, Part II -section 3, Sub-section (I)
Ministry Of Health And Family Welfare (Department Of Health)
3. Ansel’s Pharmaceutical Dosage forms and Drug Delivery
system ;L. V. Allen et al. ; eight edition; Current good
manufacturing practices and current good compounding
practices;67-91
4. Quality Assurance of Pharmaceuticals; Good manufacturing
practices and inspection; Volume – 2; WHO
5. Encyclopedia of pharmaceutical technology; third edition; volume
– 1;Good Manufacturing Practices(GMPs): An overview;1941-
1994