Name :- Neha Anand Bamane
Roll No:- 02
Subject:- Microbilogy Practices
Topic : -Schedule M
Teacher Incharge:- Dr. Suhas Mangoakar .
Understanding Schedule M
What is Schedule M under Drugs and Cosmetics Act 1940?
Schedule M part of Drugs and Cosmetics Act 1940 deals with Good Manufacturing
Practices for pharmaceuticals that should be followed by pharmaceutical manufacturing
units in India. Schedule M guides on Good Manufacturing Practices regarding company
premises, quality control system, quality check laboratories, production, cleaning of
equipment, housekeeping, cross-contamination, and other related topics.
•Schedule M-I: Deals with the requirements of factory premises for manufacturing of
Homeopathic preparations.
•Schedule M-II: Deals with the requirements of premises, plant, and equipment for
manufacture of cosmetics.
•Schedule M-III: Deals with the requirements of premises, plant, and equipment for
manufacture of Medical devices.
Objectives
• To help a manufacturer better recognize, investigate, and take appropriate
planned action for manufacture of drugs and cosmetics.
• To protect consumer and marketplace from exposure to any potentially harmful
ingredients or practices.
• To adopt strict, risk-based practices and procedures for their manufacturing facility
with a good manufacturing practice facility registration.
Schedule M PART -1: GMP for premises & materials
• Part 1- Specific requirements for the manufacture of sterile products, parenteral preparations, &
sterile ophthalmic preparation
• part 1B- Specific requirements for the manufacture of oral solid dosage forms.
• Part 1C -Specific requirements for the manufacture of oral liquids.
• Part 1D- Specific requirements for the manufacture of topical preparations.
• Part 1E- Specific requirements for the manufacture of metered dose inhalers (MDI).
• Part 1F - Specific requirements for the manufacture of active pharmaceutical ingredients (bulk
drugs).
Part I: GMP for Premises and Materials
1. General requirement
2. Warehousing area
3. Production area
4. Ancillary area
5. QC area
6. Personnel
7. Health , clothing sanitation of workers
8. Mfg operations and controls
9. Sanitation in Mfg premises
10. Raw materials
11. Equipments
12. Documentation and records
13. Labels and printed materials
14. QA
Schedule M Part I General requirement Location and surrounding
• 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
• 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 compatible with other
drug manufacturing operations’ adequate working space to avoid the risk
of mix-up between different materials & avoid the possibilities of
contamination and cross-contamination.
Schedule M Part I General requirement Location and surrounding
• 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
Schedule M Part I Warehousing Area Production 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 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
Schedule M Part I 4. Ancillary Areas And 5. Quality Control Area.
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.4. Ancillary Areas5. Quality Control Area.
THANK YOU
