Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 18 – Good practices in production - December 30, 2024
- Key Notes on Revised Schedule M: Point No. 17 – Documentation - December 29, 2024
- Key Notes on Revised Schedule M: Point No. 16 – Waste materials - December 28, 2024
Last Updated on January 1, 2025 by The Health Master
Documentation
Key considerations for Point No. 17 –Documentation for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 16 – Waste materials
Documentation Requirements for Pharmaceutical Manufacturers
To comply with Good Manufacturing Practices (GMP), pharmaceutical manufacturers must ensure that:
Comprehensive Documentation:
All aspects of manufacturing and control are documented, including specifications, procedures, and records.
Document Design and Control:
- Documents are designed, reviewed, and approved by authorized personnel.
- Documents are clear, unambiguous, and easy to understand.
- Documents are regularly reviewed and updated.
- Changes to documents are authorized, dated, and signed.
- Records are made promptly and accurately.
- Electronic records are secure and backed up.
Labeling:
Labels are clear, unambiguous, and in the company’s format.
Finished products are labeled with:
- Product name
- List of active ingredients
- Batch number
- Expiry date
- Storage conditions
- Directions for use
- Manufacturer’s name and address
Specifications and Testing Procedures:
Testing procedures are validated.
Specifications are established for:
- Starting materials
- Packaging materials
- Intermediate products
- Bulk products
- Finished products
- Specifications are reviewed periodically.
- Reference standards and pharmacopoeias are available.
Master Formula Records:
A master formula record exists for each product and batch size.
Records include:
- Product name and code
- Dosage form and strength
- List of starting materials
- Expected yield
- Processing instructions
- In-process controls
- Storage conditions
Packaging Instructions:
Formally authorized packaging instructions exist for each product.
Records include:
- Product name and description
- Pack size
- Packaging materials
- Packaging operations
- In-process controls
Batch Processing and Packaging Records:
Batch processing and packaging records are kept for each batch.
Records include:
- Product name and batch number
- Dates and times of processing stages
- Personnel involved
- Quantities of materials used
- In-process control results
- Yields
- Deviations from procedures
Standard Operating Procedures (SOPs):
SOPs are available for:
- Equipment assembly and validation
- Analytical apparatus and calibration
- Maintenance, cleaning, and sanitation
- Personnel matters
- Environmental monitoring
- Pest control
- Complaints, recalls, and returns
- SOPs for material receipt, storage, and sampling are in place.
- SOPs for batch numbering and testing procedures are followed.
- Records are maintained for equipment validation, calibration, maintenance, and cleaning.
- Cleaning and sanitation procedures are documented and followed.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 18 – Good practices in production
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
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
