Last Updated on December 4, 2024 by The Health Master
Revised Schedule M
The pharmaceutical industry in India is undergoing significant regulatory changes with respect to revised Schedule M.
To help businesses adapt to these changes, the Central Drugs Standard Control Organization (CDSCO), in collaboration with the Food and Drug Control Administration (FDCA) Gujarat and the Indian Drug Manufacturers Association (IDMA), is organizing a crucial workshop.
Key Takeaways from the Workshop:
- Understanding the Revised Schedule M: This workshop will provide a comprehensive overview of the latest amendments to Schedule M, focusing on vendor validation and audit processes.
- Expert Insights: Industry experts and regulatory authorities will delve into the practical implications of the revised guidelines.
- Interactive Sessions: Participants will have the opportunity to engage in Q&A sessions and group discussions to clarify doubts and share best practices.
- Compliance Expectations: CDSCO and FDCA Gujarat will share insights into compliance expectations, ensuring that organizations can align their operations with regulatory requirements.
Why is Vendor Validation and Audit Crucial?
The revised Schedule M emphasizes the importance of robust vendor validation and audit processes.
By implementing these practices, pharmaceutical companies can:
- Ensure Product Quality: Verify that suppliers adhere to Good Manufacturing Practices (GMP) and other quality standards.
- Mitigate Risks: Identify and address potential quality and compliance risks associated with suppliers.
- Enhance Supply Chain Reliability: Build strong relationships with reliable and compliant suppliers.
Key Requirements Under the Revised Schedule M:
- Equipment Qualification and Validation: Companies must ensure that their equipment is qualified and validated to meet GMP standards.
- Pharmaceutical Quality System (PQS): Implement a robust PQS to manage quality throughout the product lifecycle.
- Quality Risk Management (QRM): Identify, assess, and control quality risks.
- Product Quality Review (PQR): Regularly review product quality data to identify trends and potential issues.
- Computerized Systems: Utilize validated computerized systems to manage drug products.
By attending this workshop, pharmaceutical companies can position themselves for long-term success in the Indian market.
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Who should attend this workshop?
Pharmaceutical professionals
Regulatory experts
Quality assurance personnel
Supply chain managers
Other stakeholders in the pharmaceutical industry -
What are the key benefits of attending this workshop?
Gain a deep understanding of the revised Schedule M guidelines
Learn best practices for vendor validation and audit
Network with industry experts and regulatory authorities
Stay updated on the latest regulatory requirements
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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