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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