Transcription of SCHEDULE M
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SCHEDULE M
[ SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT 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.
pharmaceutical products like penicillin or biological preparations with live micro-organisms. Separate dedicated facilities shall be provided for the manufacture of contamination causing and potent products such as Beta-Lactum, sex hormones and cytotoxic substances. 3.3. Working and in-process space shall be adequate to permit orderly and
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