Regulation
Revised Schedule M, Drugs Rules, 1945 (India)
Published by Ministry of Health and Family Welfare / CDSCO
India's GMP requirements, revised in December 2023 to align more closely with WHO and PIC/S.
Why it matters to you: The legal minimum for every manufacturer in India, inspected by CDSCO and state authorities.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| Quality system | Pharmaceutical quality system | Risk management, product quality review |
| Sterile products | Requirements for sterile manufacture | Grades, EM, validation |
| QC laboratory | Laboratory controls | Methods, records, reference standards |
Practical tips
- Check transition timelines that applied to your company size.
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Other standards
Summarised in our own words for learning. Always refer to the current official text for exact requirements. How we use references