World Health Organisation-Good Manufacturing Practices Certification

• 05 Aug 2023

Recently, in an effort to enhance the quality management standards of Indian pharmaceutical manufacturers on a national and global scale, the Health Ministry has introduced a deadline for small manufacturers for six months, while larger units have a year to acquire their World Health Organisation-Good Manufacturing Practices (WHO-GMP) certification.

Key Points

• Aim: The Health Ministry's move aims to foster the growth of the Indian pharmaceutical sector both domestically and internationally.
• Challenges and Motivation: Based on findings from ongoing risk-based inspections, it became apparent that a reassessment of the current GMP regulations and Quality Management Systems used by pharmaceutical manufacturers was necessary.
• Issues identified during inspections encompassed various areas such as documentation, validation shortcomings, absence of self-assessment, and more.

About GMP

• Introduction: Originally introduced in 1988 within Schedule M of the Drugs and Cosmetics Rules, 1945, with the last amendment in June 2005, WHO-GMP standards are now integrated into the revised Schedule M. (Schedule M part of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India).
• Significance of GMP: Good Manufacturing Practices (GMP) entail essential standards that ensure product quality through oversight of materials, methods, machinery, processes, personnel, and facilities.
• Consequences of Non-Compliance: WHO-GMP certification remains valid for three years. Violations could result in the cancellation of licenses and monetary penalties.
• Enhancements with Revised Schedule M: The revised Schedule M introduces several significant changes, including the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), equipment qualification and validation, change control management, self-inspection, and more.