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.
2.10. Sampling and dispensing of sterile materials shall be conducted under aseptic conditions conforming to Grade A, which can also be performed in a dedicated area within the manufacturing facility. 2.11. Regular checks shall be made to ensure adequate steps are taken against spillage, breakage and leakage of containers. 2.12.
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