Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 10 – Self Inspection - December 19, 2024
- Key Notes on Revised Schedule M: Point No. 9 – Production under Loan License - December 17, 2024
- Key Notes on Revised Schedule M: Point No. 8 – Change Control - December 15, 2024
Last Updated on December 19, 2024 by The Health Master
Self Inspection
Key considerations for Point No. 10 – Self Inspection compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 9 – Production under Loan License
Self Inspection, Quality Audits, and Supplier’ Audits and approval
To ensure adherence to GMP standards, pharmaceutical manufacturers must:
Conduct Regular Self Inspections:
- Evaluate compliance with GMP standards across all production and QC aspects.
- Identify shortcomings and implement corrective actions.
- Schedule inspections routinely and on special occasions (e.g., product recalls, repeated rejections, regulatory inspections).
- Appoint a self inspection team of GMP experts.
- Document self inspection procedures and maintain effective follow-up programs.
Establish written instructions for:
- Self inspections,
- Covering personnel,
- Premises,
- Maintenance,
- Storage,
- Equipment,
- Production controls,
- QC,
- Documentation,
- Sanitation,
- Validation,
- Calibration,
- Recall procedures,
- Complaint management,
- Label control, and
- Previous inspection results.
Perform Quality Audits:
- Supplement self inspections with quality audits conducted by external or internal experts.
- Assess the quality system to identify areas for improvement.
- Extend audits to suppliers and contractors as needed.
Conduct Supplier Audits and Approvals:
- Establish a process for approving suppliers who can reliably provide compliant starting and packaging materials.
- Evaluate suppliers based on their history, the nature of materials supplied, and their adherence to GMP standards.
- Conduct audits to assess a supplier’s ability to meet GMP requirements before approval.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 11 – Personnel ….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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