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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 Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 2 – Quality Risk Management
Key Notes on Revised Schedule M: Must read
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Blood Centre (Blood Bank)
Procedure to obtain license for Commercial Testing Laboratories
Procedure to obtain license for Medical Store / Pharmacy
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