Regulatory guidance
EudraLex Volume 4: EU Good Manufacturing Practice
Published by European Commission
The GMP rules for Europe, including Annex 1 for sterile products. PIC/S uses the same text.
Why it matters to you: The most detailed guidance on sterile manufacturing; the working standard for many Indian sterile sites.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| Annex 1 | Manufacture of sterile medicinal products | CCS, grades A–D limits, APS, PUPSIT, barrier technology |
| Chapter 6 | Quality control | Testing, OOS, reference standards |
| Annex 11 | Computerised systems | Audit trails, access, backups |
| Annex 15 | Qualification and validation | IQ/OQ/PQ, method and process validation |
| Chapter 1 | Pharmaceutical quality system | Deviations, CAPA, change control |
Practical tips
- Grade A limits are 'no growth' for every sample type.
- Every EM excursion should be traceable to a review of the CCS.
Learn and test yourself
Other standards
Summarised in our own words for learning. Always refer to the current official text for exact requirements. How we use references