Regulatory guidance
Pharmaceutical Inspection Co-operation Scheme
Published by PIC/S
A co-operation of GMP inspectorates. PIC/S GMP guides mirror EU GMP.
Why it matters to you: PIC/S member inspectors use the same expectations, and its data integrity guide is widely cited.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| PE 009 | PIC/S GMP Guide | Same structure as EU GMP, including Annex 1 |
| PI 041 | Good practices for data management and integrity | ALCOA+ in regulated environments |
Practical tips
- Use PI 041 when designing audit trail reviews and paper record controls.
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