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Contract Research and Manufacturing Services (CRAMS) in India by G Gokhale, M Antani

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Appendix 3: Schedule M

Relevant sections of Schedule M are reproduced below.

[See Rules 71, 74, 76 and 78]

GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISESPLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS

Note: – To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein.

PART 1 GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS

1 GENERAL REQUIREMENTS

1.1. Location and surroundings.- The factory building(s) for manufacture of drugs shall be so situated and ...

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