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THE PHARMA REVIEW (NOVEMBER DECEMBER 2019)

GMP: The Key Requirements for Manufacturing of Quality Standard Ayurvedic Siddha and Unani Medicine

Anzar Alam1, Sanjay Kumar2, Karunanidhi Sharma2, Pooja Mehta2 & Himanshu S Tiwari3

Introduction: Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled to the quality standards appropriate to their intended use. Rule 157 of the Drugs and Cosmetics (D&C) Rules, 1945 requires the compliance to GMP for grant or renewal of license to manufacture Ayurveda, Siddha and Unani (ASU) medicine. Schedule T under that Rule prescribes the GMP guidelines. The factory premises of ASU manufacturing plant should have adequate space for receiving and storing raw materials, manufacturing process areas, quality control section, finished goods store, rejected goods/drugs store and office. Part-I of Schedule T prescribes general requirement for manufacturing unit and requirement for sterile product separately. Part-II of the schedule describes the list of recommended machinery, equipment and minimum manufacturing premises required for the manufacture of various categories of ASU medicine and list of equipment recommended for in-house quality control section. There is supplementary guidelines for manufacturing of mineral/metal based formulations in Schedule T.

 

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