What are the major changes notified in the revised Pharma manufacturing rules under schedule M by the Health Ministry in India
The Health Ministry in India has recently notified revised rules for Pharma manufacturing under schedule M. Discuss the important changes introduced.
The Health Ministry in India has introduced revised rules for Pharma manufacturing under schedule M. The major changes notified include:
- Streamlining of Good Manufacturing Practices (GMP): The new rules aim to bring transparency and clarity to the manufacturing practices in the pharmaceutical industry.
- Enhanced focus on Quality Control: The revised schedule M emphasizes the importance of quality control procedures to ensure the safety and efficacy of drugs.
- Mandatory Training and Certification: The new rules mandate training and certification for personnel involved in different manufacturing functions, including quality control, production, and maintenance.
- Updated Documentation requirements: Manufacturers are now required to maintain up-to-date documents related to manufacturing, quality assurance, and quality control.
- Introduction of Risk Management Practices: The revised schedule M emphasizes the implementation of risk management practices to identify and mitigate potential risks in the manufacturing process.
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