India: Health Ministry Revised Schedule M for GMP
The Indian Health Ministry has introduced revised rules under Schedule M of the Drugs and Cosmetics Rules, aimed at ensuring robust quality control for pharmaceutical and biopharmaceutical products. Schedule M outlines Good Manufacturing Practices (GMP) for pharmaceutical products.
The revision includes a shift from 'Good Manufacturing Practices' to 'Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products.' The changes aim to align GMP recommendations with global standards, particularly those of the World Health Organization (WHO).
Notable additions in the revised schedule include a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), equipment qualification and validation, and a computerized storage system for drug products. The rules emphasize manufacturers' responsibility for ensuring product quality, compliance with license requirements, and avoiding risks to patient safety.
The revised schedule is set to be implemented based on company turnovers, with different timelines for small & medium and large manufacturers (12 and 6 months). The move is seen as a positive step for the Indian pharmaceutical sector, enhancing quality standards and supporting the industry's global reputation.
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