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

Key considerations for Pharmaceutical Quality System (PQS) compliance under revised Schedule M are outlined in the article.

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Key Notes Revised Schedule M
Key Notes Revised Schedule M
Rakesh Dahiya

Last Updated on December 14, 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.

Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


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

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