Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on December 15, 2024 by The Health Master
Revised Schedule M
To ensure the production of high-quality drugs, pharmaceutical manufacturers must adhere to 20 key points outlined in the Main Principles for Good Manufacturing Practices (GMP) in revised schedule M.
We’ve created concise notes from the revised schedule M for each point to guide manufacturers in maintaining GMP standards.
Click the below links to read more:
1. Pharmaceutical Quality System
Key Notes on Revised Schedule M: Point No. 1 – Pharmaceutical Quality System
2. Quality Risk Management
Key Notes on Revised Schedule M: Point No. 2 – Quality Risk Management
3. Good Manufacturing Practice (GMP)
Key Notes on Revised Schedule M: Point No. 3 – Good Manufacturing Practice (GMP)
4. Sanitation and Hygiene
Key Notes on Revised Schedule M: Point No. 4 – Sanitation and Hygiene
5. Qualification and validation
Key Notes on Revised Schedule M: Point No. 5 – Qualification and validation
6. Complaints and Adverse reaction
Key Notes on Revised Schedule M: Point No. 6 – Complaints and Adverse reaction
7. Product Recall
Key Notes on Revised Schedule M: Point No. 7 – Product Recall
8. Change Control
Key Notes on Revised Schedule M: Point No. 8 – Change Control
Point 9 to 20 ………………………coming soon
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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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