MoHFW Notifies Revised Pharma Manufacturing Rules under Schedule M to Ensure Quality Control.

National

The revised Schedule M includes the introduction of a pharma quality system (PQS), quality risk management (QRM), product quality review (PQR), and specific guidelines for the qualification and validation of equipment. It also mandates a computerised storage system for all drug productsWith an aim to bring better compliance with quality standards, the Ministry of Health and Family Welfare (MoHFW) notified the revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945, in the Gazette of India on Saturday. Schedule M prescribes the good manufacturing practices (GMP) for pharmaceutical products.


      Schedule M prescribes Good Manufacturing Practices (GMP) for pharmaceutical products. The revised Schedule M will upgrade the GMP in India to global standards.

      The revised Schedule M has been notified as rules to ensure ‘Good Manufacturing Practices (GMP) and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.’

      Schedule M part of the Drugs and Cosmetics Act 1940 deals with ‘GMP’ to be followed by pharmaceutical manufacturing units in India.

 

     


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