- Key Notes on Revised Schedule M: Investigational Pharmaceutical Products - February 6, 2025
- Key Notes on Revised Schedule M: Phytopharmaceuticals - January 25, 2025
- Key Notes on Revised Schedule M: Radiopharmaceutical Products - January 20, 2025
Last Updated on January 10, 2025 by The Health Master
Good practices in quality control
Key considerations for Point No. 19 –Good practices in quality control for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 18 – Good practices in production
Pharma Manufacturer’s Compliance with Good Manufacturing Practices (GMP) for Quality Control
Key Principles and Responsibilities:
Independent QC Function:
- Establish a dedicated QC department independent of production.
- Appoint a qualified and experienced head of QC.
- Allocate sufficient resources to ensure effective QC operations.
Quality Control Procedures:
- Develop, validate, and implement written procedures for all QC activities.
- Establish and maintain reference standards for substances.
- Ensure correct labeling of materials and products.
- Monitor the stability of active pharmaceutical ingredients and products.
- Participate in investigations of product quality complaints.
- Contribute to environmental monitoring and quality risk management.
Sampling and Testing:
- Sample materials and products according to approved procedures to avoid contamination and ensure representativeness.
- Conduct tests as per written procedures and review results before releasing or rejecting materials/products.
- Maintain records of all sampling, testing, and investigations.
- Retain sufficient samples for future examination.
Material and Product Control:
- Test starting and packaging materials for identity, strength, purity, and other quality parameters.
- Conduct identity tests on each container of starting material or establish a validated exemption procedure.
- Examine printed packaging materials upon receipt.
- Accept certificates of analysis from reliable suppliers with validated testing procedures.
- Maintain in-process control records.
- Conduct laboratory tests on each drug batch to ensure conformity to specifications.
- Reject products that fail to meet specifications or quality criteria.
Batch Record Review and Retention:
- Review QC records as part of the batch release process.
- Investigate any deviations or failures to meet specifications.
- Retain finished product samples for at least one year after the expiry date.
- Retain active starting material samples for at least one year beyond the expiry date of the corresponding finished product.
- Retain other starting materials for a minimum of two years.
Stability Studies:
- Evaluate the quality and stability of finished products, starting materials, and intermediate products.
- Establish expiry dates and shelf-life specifications based on stability data.
- Develop and implement a written stability program.
- Conduct stability studies before marketing and after significant changes.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 20 – Computerised systems ….coming soon
Key Notes on Revised Schedule M: Compilation
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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