SCHEDULE M

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[ 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.

the Bio-Medical Waste (Management and Handling) Rules, 1996. (iii) Additional precautions shall be taken for the storage and disposal of rejected drugs. Records shall be maintained for all disposal of waste. (iv) Provisions shall be made for the proper and safe storage of waste materials awaiting disposal. Hazardous,toxic substances and

  Management, Medical, Schedule, Waste, Handling, Bio medical waste, Management and handling