Revised schedule M for Good Manufacturing Practices

Content Editor: Dr. Tanya Tanu

January 24, 2024 at 12:30:00 PM

Schedule M, Good Manufacturing Practices

GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945, in the year 1988 for pharmaceutical products and the last amendment was done in June 2005.
The revised Schedule M was notified on December 28, 2023, to ensure GMP is adhered to, and the requirements of premises, plant, and equipment for pharmaceutical products.
The changes in the revised Schedule M include:

Introduction of a pharmaceutical quality system.
Quality risk management.
Product quality review.
Qualification and validation of equipment.
Computerized storage system for all drug products.
To market a finished product by companies only after getting “satisfactory results” on tests of the ingredients.
To retain sufficient quantities of the samples of intermediate and final products to allow repeated testing or verification of a batch.