Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 8 – Change Control - December 15, 2024
- Forms: All types for Hospital RMI - December 14, 2024
- Key Notes on Revised Schedule M: Point No. 7 – Product Recall - December 14, 2024
Last Updated on December 16, 2024 by The Health Master
Change Control
Key considerations for Point No. 8 – Change Control compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 7 – Product Recall
Good Manufacturing Practices (GMP) for Pharmaceutical Products: Change Control
Pharmaceutical manufacturers must adhere to the following principles for effective change control:
Formal Change Control System:
- Establish a formal system to evaluate all changes affecting product production and control.
Written Procedures:
Develop written procedures for identifying, documenting, reviewing, and approving changes in:
- Raw materials
- Specifications
- Analytical methods
- Facilities
- Support systems
- Equipment (including computer hardware)
- Processing steps
- Labeling and packaging materials
- Computer software
GMP Change Approval:
- Draft, review, and approve proposals for relevant GMP changes by appropriate organizational and quality units.
Impact Assessment:
- Evaluate the potential impact of proposed changes on the quality of intermediates, APIs, or finished products.
- Use a classification procedure to determine the level of testing, validation, and documentation needed to justify changes to validated processes.
- Employ scientific judgment to determine additional testing and validation studies required for justified changes.
Change Implementation:
- Ensure all affected documents are revised to reflect implemented changes.
Post-Change Evaluation:
- Evaluate the first batch produced or tested under the new conditions.
Retest/Expiry Date Impact:
- Assess the potential impact of critical changes on established retest or expiry dates.
- Consider accelerated stability programs or additional stability monitoring for samples produced by the modified process.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 9 – Production under Loan License and Contract Analysis ….coming soon
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
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