Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Biological products - January 15, 2025
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Last Updated on January 15, 2025 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
9. Production under Loan License
Key Notes on Revised Schedule M: Point No. 9 – Production under Loan License
10. Self Inspection
Key Notes on Revised Schedule M: Point No. 10 – Self Inspection
11. Personnel
Key Notes on Revised Schedule M: Point No. 11 – Personnel
12. Premises
Key Notes on Revised Schedule M: Point No. 12 – Premises
13. Equipment
Key Notes on Revised Schedule M: Point No. 13 – Equipment
14. Materials
Key Notes on Revised Schedule M: Point No. 14 – Materials
15. Reference Standards
Key Notes on Revised Schedule M: Point No. 15 – Reference Standards
16. Waste materials
Key Notes on Revised Schedule M: Point No. 16 – Waste materials
17. Documentation
Key Notes on Revised Schedule M: Point No. 17 – Documentation
18. Good practices in production
Key Notes on Revised Schedule M: Point No. 18 – Good practices in production
19. Good practices in quality control
Key Notes on Revised Schedule M: Point No. 19 – Good practices in quality control
20. Computerised systems
Key Notes on Revised Schedule M: Point No. 20 – Computerised systems
Tablets & Capsules (OSDF)
Key Notes on Revised Schedule M: Tablets & Capsules (OSDF)
Oral Liquids
Key Notes on Revised Schedule M: Oral Liquids
Topical Products (External Preparations)
Key Notes on Revised Schedule M: Topical Products (External Preparations)
Sterile products {Steroids (Anabolic, Androgenic) or Cytotoxic Substances}
Key Notes on Revised Schedule M: Sterile products
Sex Hormones {Steroids (Anabolic, Androgenic) or Cytotoxic Substances}
Key Notes on Revised Schedule M: Sex Hormones
Biological products
Key Notes on Revised Schedule M: Biological products
Key Notes on Revised Schedule M: API (Active Pharmaceutical Ingredients) ………………………coming soon
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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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