DRUGS AND COSMETICS ACT 1940 AND RULES THEIR UNDER 1945 SCHEDULE M. BY: Mr.Tushar D. Morankar RCPIPER, Shirpur MH425405

1. Morankar Tushar D.
DRUGS AND COSMETICS ACT 1940 AND
RULES THEIR UNDER 1945

2. CONTENTS
Introduction
Schedule M
Part I
Part II
Schedule M I
Schedule M II
Schedule M III

3. 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

4. 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

5. 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.

6. SCHEDULE M

7. PART -1
GMP for premises & materials
• Specific requirements for manufacture of sterile
products, parenteral preparations, & sterile
ophthalmic preparation
• Specific requirements for manufacture of oral solid
dosage forms
• Specific requirements for manufacture of oral
liquids
• Specific requirements for manufacture of topical
preparations
• Specific requirements for manufacture of metered
dose inhalers(MDI)
• Specific requirements for manufacture of active
pharmaceutical ingredients
Part 1A
Part 1B
Part 1C
Part 1D
Part 1E
Part 1F

8. 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

9. The premises used for manufacturing, processing,
warehousing, packaging, labeling and testing purposes
shall be
iii.
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
designed / constructed / maintained to prevent
entry of insects, pests, birds, and rodents
iv. Well illuminated, effectively ventilated, with proper
Air Handling Units

10. 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

11. 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-MedicalWaste (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

12. 2.
WAREHOUSING
AREA
Adequat
e areas
to allow
orderly
warehou
sing of
various
categori
es of
material
s.
Good
storage
conditions
There
shall be
a
separate
sampling
for
active
raw
material
s and
excipient
s
2.4.
Segregat
ion shall
be
provided
for the
storage
of
rejected,
recalled
or
returned
material
s or
products
2.5
Highly
hazardo
us,
poisono
us and
explosiv
e
material
s shall
be
stored in
safe and
secure
areas

13. 3.
PRODUCTION
AREA
•Separate dedicated and self-contained
facilities shall be made available for the
production of sensitive pharmaceutical
products
•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
•Services lines shall preferably be identified by
colours and the nature of the supply and
direction of the flow shall be marked/indicated

14. 4.
ANCILLARY
AREAS
•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.
•Animal houses shall be those as prescribed in
Rule 150-C(3) of the Drugs andCosmetics Rules,
1945 which shall be adopted for production
purposes.

15. 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.

16. 6.
PERSONNEL
•Qualifications and practical experience in the
relevant field
• Written duties of technical andQuality Control
•personnel shall be laid and follow strictly
•Number of personnel employed shall be adequate and
in direct proportion to the workload

17. 7. HEALTH,
CLOTHING
AND
SANITATION
OF
WORKERS
•Prior to employment, all personnel, shall undergo
medical examination and a periodically examination is
carried out, records are also maintained
•Proper training shall be given to all employees to
maintain personnel hygiene and adequate facilities for
personal cleanliness
•Smoking, eating, drinking, chewing , food, drink and
personal medicines not permitted in production,
laboratory, storage area

18. 8. MANUFACTURING OPERATIONSAND
CONTROLS
8.1 All manufacturing operations shall be carried out
under the supervision of technical staff approved by
the Licensing Authority
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

19. 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

20. 9. SANITATION INTHE
MANUFACTURINGPREMISES
•The manufacturing premises shall be cleaned and in an
•orderly manner
•The manufacturing areas shall not be used for other operations
•A routine sanitation program shall be drawn up which shall be
properly recorded and which indicate–
• specific areas to be cleaned and cleaning intervals
• cleaning procedure to be followed
• personnel assigned to and responsiblefor the
cleaning operation.

21. 10. RAW
MATERIALS
•Keeping an inventory of all raw materials to be
•used and maintain records as per Schedule U
•Authorized staff who examine each consignment for
its integrity
•Labeling with the following information:
• Name of the product and
the internal code reference and
analytical reference number
• Manufacturer’s name, address and batch number
• The status of the contents (e.g.Quarantine,
under test, released, approved, rejected)
• The manufacturing date, expiry date and re- test
date.

22. 11.
EQUIPMENT
•Equipment shall be located,
designed, constructed,
•adapted to suit the operations and log book is
maintained
•Equipment shall be calibrated and checked on a
scheduled basis in accordance to SOP and maintain
records
•Equipment shall be inert and defective are removed
and labeled

23. 12.
DOCUMENTATION
ANDRECORDS
•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

24. 1.Documents shall be approved, signed and dated by
authorized persons
2.Documents shall specify : the title, nature and
purpose laid out in an orderly fashion & kept up to date
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

25. 13. LABELS
ANDOTHER
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
All containers and equipment shall bear appropriate
labels
Prior to release, all labels for containers shall be
examined by the QC Department
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.

26. 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 andGCP
• 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

27. 15. SELF
INSPECTION
AND
QUALITY
AUDIT
•It is for the assessment of all or part of a system withthe
•specific purpose of improving it
•15.1The 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.
• 15.2The procedure for self-inspection shall be
documented indicating self-inspection results;
evaluation, conclusions and recommended
corrective actions with effective follow up program

28. 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
.

29. QC lab should have qualified and experience staff
QC lab may be divided into Chemical, Instrumentation,
Microbiological and Biological testing
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
All instruments shall be calibrated and validated before
adopted for routine testing
Pharmacopoeia, reference standards, working
standards, references spectra, other reference materials
and technical books, as required, shall be available in the
QC Laboratory

30. 17.
SPECIFICATION
17.1 For raw materials and packaging
materials They shall include:
• The designated name and internal code reference
• Reference, if any, to a pharmacopoeial
monograph
• Qualitative and quantitative requirements with
acceptance
• limits
• Name and address of manufacturer or supplier
and original manufacturer of the material
• Specimen of printed material
• Directions for sampling and testing or reference
to procedures
• Storage conditions and
• Maximum period of storage before re-testing

31. 17.2 For finished products.
Appropriate specifications for
finished products shall include:
• The designated name of the product and the
code reference
• The formula or a reference to the formula and
the pharmacopoeial reference
• Directions for sampling and testing or a
reference to procedures
• A description of the dosage form and package
details
• The storage conditions and precautions, where
• applicable
• The shelf-life

32. 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 name of the product together with product reference
code relating to its specifications
•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
•name, quantity, and reference number of all the
•starting materials to be used
The master Formula
shall include:

33. A statement of the
processing
location and the
principal
equipment to be
used
detailed stepwise
processing
instructions and
the time taken for
each step
the instructions for
in-process control
with their limits
the requirements
for storage
conditions of the
products,
including the
container, labeling
and special
storage conditions
where applicable
any special
precautions to be
observed and
packing details
and specimen
labels

34. 19.
PACKING
RECORDS
These shall include or have a
reference to the following:
Name of the product
Description of the
dosage form, strength
and composition
The pack size expressed
in terms of the number
of doses, weight or
volume of the product in
the final container
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.
There shall be authorised packaging
instructions for each product, pack
size and type

35. 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

36. 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

37. 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
EndotoxinTest, 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

38. 24.
REPROCESSING
AND
RECOVERIES:
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
25.DISTRIBUTION RECORDS:
Recovery of product residue may be carried out , if permitted, in the
master production
Where reprocessing is necessary, written procedures shall be
established & approved by quality assurance department

39. 26.VALIDATIONAND 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

40. 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

41. 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

42. PART 1A: sterile products
• 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
General :
• Built of standardized material to avoid cracks
in critical areas
• Manufacturing area clearly separated into
support areas, preparation areas, change
areas and aseptic areas
Buildings and civil works:

43. 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

44. • Air handling system:
▪Critical areas conforming to grade B,C & D have separate
air handling units
Grade Class Operations
GradeA 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

45. • 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

46. • Include component washing machines,
steam sterilizers, membrane filters, liquid
& powder filling machine , sealing &
labelling machines etc
Equipment
Water and
steam system
• Potable water – microbiological
specification(<500cfu/ml) &
• Absence of individual pathogens per
100ml used for preparation of purified
water
• Steam coming in contact with products
primary containers shall be sterile &
pyrogen free
• Bulk raw materials monitored for bio-
burden periodically
• A limit of not more than 100cfu/ml is
recommended
• Finished products shall be filled in
continuous operation with great care
Manufacturing
process

47. Sterilization
• Terminal sterilization(filling of products) - gradeA
• Preparation of solution(sterilized by filtration) -
grade C
• Sterilization process should be validated
• Biological/ chemical indicators – to monitor
sterilization
• Records related to manufacture of products
should be maintained
Documentation

48. 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

49. 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

50. • Stored in conditions which ensure safety from effects of
excessive heat & moisture
Filling of hard gelatin capsules
• Special care must be taken to avoid product mix-up during
printing
• Done using edible colors & suitable printing ink
Printing(tablets & Capsules)
• Before packaging operation all ‘rogue’ tablets & capsules are
removed
• Strips - inspected for defects such as misprint, cut on foil,
missing tablets & improper sealing
Packaging

51. 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

52. 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

53. ➢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:
the area▪Where products or clean components are exposed,
shall be supplied with filtered air of grade C
➢Equipment:
▪Manufacturing equipment – closed system where vessels &
supply lines are stainless steel
PART 1E : MDIs

54. • 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

55. 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

56. 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

57. 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

58. 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

59. 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
PART II

60. Oral liquid
preparation:
Basic installation area:30sq.m
Ancillary area:10sq.m
• 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
Equipments include:

61. 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,
granulatio
n & drying
section
Tablet
compressi
on section
Packaging
section
Coating
section
(wherever
required)

62. • Disintegrator & sifter
• Powder mixer
• Granulator wherever required
• Thermostatically controlled hot air oven
• Weighing machines
Mixing, granulation & drying section:
• Tablet compression machine
• Punch & die storage cabinets
• Tablet de-duster
• Tablet inspection unit
• Dissolution test apparatus
• In-process testing apparatus
• Air conditioning & dehumidifier
Compression section:

63. 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

64. • Basic installation area: 30sq.m
• Equipments include:
• Disintegrator
• Mixer (electrically operated)
• Sifter
• Stainless steel vessels
• Filling equipment
Powders:
• Basic installation area: 25sq.m
• Ancillary area:10sq.m
• Equipments include:
• Mixing & blending equipment
• Capsule filling unit
• Capsule counters &
• Polishing equipment
Capsules:

65. • 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
Surgical dressing:
• 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
Ophthalmic preparations :

66. • Basic installation area:20sq.m
• Equipments include:
• Mixing & pouring equipment
• Molding equipment
• Weighing devices
Pessaries & suppositories:
• Basic installation area: 20sq.m
• Equipments include:
• Mixing equipment
• Graduated delivery equipment
• Sealing equipment of medicament
during filling
Inhalers :

67. Repacking of
drugs &
pharmaceutical
chemicals:
Equipments include:
Sifter
Stainless
steel
vessels
Weighing
&
measuring
equipment
Filling
equipment
Electrical
sealing
machine
Basic installation
area: 30sq.m

68. 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

69. • 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

70. SCHEDULE M-I
Requirements
of factory
premises of
homoeopathic
preparations
General Requirements:
Location and Surroundings;
Buildings;Water supply
Health, Clothing and
Sanitation of Workers;
Medical Services, container
management etc. comes
under this.
Requirements of Plant and
Equipment:
Mother tinctures and Mother solution
Section- An area of 55 sq. meters is
recommended for basic installations
Potentisation Section- Method of
potentisation will be adopted as
specified in Homoeopathic
Pharmacopoeia of India Vol.I

71. SCHEDULE M-II : Requirement of
premisesfor manufacture of cosmetics
• General Requirements: Location and Surroundings; Buildings; Water supply; Health,
Clothing and Sanitation of Workers; Medical Servicesetc
• Requirements of Plant and Equipment: Specifications are givenfor
•only certain cosmetic preparationslike
• Powers
• Creams, lotions, emulsions, pastes, cleansing milks,shampoos,
•pomade, brilliantine, shaving creams, and hair-oilsetc
• Nail Polishes and Nail lacquers
• Lipsticks andlip-gloss
• Depilatories
• Preparations used forEyes
• Aerosol
• Alcoholic Fragrance Solutions
• Hair Dyes
• Toilet Soaps
• Tooth powders and toothpastes

72. SCHEDULE
M-III
Requirements
of factory
premisesfor
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 ManufactureOf Medical
Devices: Shall be conducted bat the licensed
premises, and the process of manufacture is
divided into following separate
operations/Sections-
• Moulding
• Assembling
• Raw Materials
• StorageArea
• Washing, drying and sealing area
• Sterilization
• Testing facilities

73. 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

74. CONCLUSION
• GMP is an important tool in quality controlof
drug products
• Legal regulation of GMP is
important
to control the quality of drugs manufactured with
in the country

75. REFERENCES
• Manual on Drugs andCosmetics; sixth edition; 2009
• Schedule M:Good Manufacturing PracticesAnd
RequirementsOf Premises, PlantAnd Equipment
For Pharmaceutical Products.GazetteOf India
Extraordinary, Part II -section 3, Sub-section (I)
MinistryOf HealthAnd FamilyWelfare
(DepartmentOf Health)
• 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
• QualityAssurance of Pharmaceuticals;Good
•manufacturing practices and inspection;Volume –
2; WHO
• Encyclopedia of pharmaceutical technology; third
edition; volume – 1;Good Manufacturing
Practices(GMPs):An overview;1941-1994