Key Notes on Revised Schedule M: Point No. 1 – Pharmaceutical Quality System

Last Updated on December 21, 2024 by The Health Master

Pharmaceutical Quality System

Key considerations for Point No. 1 – Pharmaceutical Quality System (PQS) compliance under revised Schedule M are outlined below.

Pharmaceutical manufacturers must adhere to these guidelines to ensure Good Manufacturing Practice (GMP) and produce high-quality drugs.

Quality Assurance:

• Assume responsibility for product quality and safety.
• Ensure compliance with licensing requirements.
• Implement a robust PQS, incorporating GMP and QRM.
• Secure senior management commitment and staff involvement.

Quality Management:

• Establish a comprehensive quality management system.
• Consider all factors influencing product quality, including design and development.
• Apply GMP throughout the product lifecycle.
• Adequately resource and maintain the PQS.

Product Quality System:

• Ensure consistent product delivery through effective system design and improvement.
• Manage product and process knowledge throughout the lifecycle.
• Design and develop products in compliance with GMP and other relevant GXPs such as those of Good Laboratory Practice (GLP) and Good Clinical Practices.
• Clearly define and document production and quality control operations.
• Specify managerial responsibilities in job descriptions.
• Control starting materials, intermediate products, and bulk products.
• Implement robust finished product processing and checking procedures.
• Ensure authorized person certification before product release.
• Manage outsourced activities effectively.
• Maintain product quality during storage, distribution, and handling.

• Conduct regular self-inspection and quality audits.
• Monitor products and processes for continuous improvement.
• Evaluate and approve planned changes before implementation.
• Review product quality regularly to identify improvement opportunities.
• Establish and maintain a state of control through effective monitoring and control systems.
• Implement appropriate quality improvements.
• Implement a QRM system.
• Report, investigate, and record deviations, suspected product defects, and other problems.
• Take corrective and preventive actions to address root causes.

Management Review:

• Conduct periodic management reviews to identify improvement opportunities.
• Involve senior management in these reviews.
• Conduct reviews at least annually, unless justified otherwise.

Documentation:

• Define and document the PQS.
• Establish a quality manual or equivalent documentation.
• Include a description of the quality management system and management responsibilities.

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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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Next: Key Notes on Revised Schedule M: Point No. 2 – Quality Risk Management

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