New Drug Manufacturing Rules Introduced to Strengthen Quality Standards

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The Union Ministry of Health and Family Welfare (MoHFW) has introduced the Drugs (Amendment) Rules, 2023. These rules have come into force from December 28, 2024. They aim to reinforce Good Manufacturing Practices (GMP) and establish stringent requirements for premises, plant, and equipment in pharmaceutical products.

The key amendment in the Drugs Rules, 1945 replace the term “Good Manufacturing Practices” with “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.” This change underscores a more comprehensive approach to ensuring the safety and quality of pharmaceutical products.

Accompanying these amendments is the implementation of a new set of guidelines titled “GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS” in Schedule M. The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control.

  1. Pharmaceutical Quality System (PQS):
    • Manufacturers must take responsibility for ensuring pharmaceutical products’ quality, safety, and efficacy.
    • Senior management plays a crucial role in implementing a comprehensive pharmaceutical quality system, incorporating GMP and Quality Risk Management (QRM).
    • The product quality system should extend to the pharmaceutical development life-cycle stages, facilitating innovation and continual improvement.
  2. Quality Risk Management (QRM):
    • A systematic process for assessing, controlling, communicating, and reviewing risks to the quality of medicinal products.
    • Evaluation of the risk to quality based on scientific knowledge and experience, with the level of effort and documentation commensurate with the level of risk.
  3. Sanitation and Hygiene:
    • Emphasis on a high level of sanitation and hygiene in all aspects of drug manufacturing.
    • Comprehensive program to eliminate potential sources of contamination.
  4. Qualification and Validation:
    • Pharmaceutical companies must identify qualification and validation work required to prove control over critical aspects of their operations.
  5. Complaints and Adverse Reactions:
    • Rigorous review of all complaints and information concerning potentially defective products.
    • Designation of responsible personnel to handle complaints and take corrective action.
  6. Product Recalls:
    • Establishment of a system to recall defective products from the market.
    • The authorized person shall coordinate and execute recalls with urgency.
  7. Change Control:
    • Implementation of a formal change control system to evaluate all changes affecting production and product control.
    • Written procedures to cover the identification, documentation, review, and approval of changes in various aspects of production.

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