Pharmacopoeia
European Pharmacopoeia
Published by EDQM, Council of Europe
Legally binding in member states of the European Pharmacopoeia Convention and used by many regulators worldwide.
Why it matters to you: Required for products sold in Europe; its chapters on rapid methods, MAT and rFC are often ahead of others.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| 2.6.1 | Sterility | Harmonised with USP <71> |
| 2.6.12 | Microbial enumeration | Harmonised with USP <61> |
| 2.6.13 | Specified micro-organisms | Harmonised with USP <62> |
| 2.6.14 | Bacterial endotoxins | Harmonised with USP <85> |
| 2.6.30 | Monocyte activation test | Detects endotoxin and non-endotoxin pyrogens |
| 2.6.32 | Recombinant factor C | Animal-free endotoxin testing |
| 5.1.4 | Microbiological quality of non-sterile products | Acceptance criteria |
| 5.1.6 | Alternative microbiological methods | Validation of rapid methods |
Practical tips
- Monograph-specific requirements can add to the general chapters; read both.
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