Regulatory guidance
WHO Good Manufacturing Practices (Technical Report Series)
Published by World Health Organization
GMP guidance published in WHO Technical Report Series annexes, used by many national regulators and for WHO prequalification.
Why it matters to you: Essential for sites supplying UN agencies and markets that follow WHO GMP.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| TRS annex | GMP for sterile pharmaceutical products | Aligned with Annex 1 principles |
| TRS annex | Water for pharmaceutical use | Design, validation and monitoring |
| TRS annex | Good practices for pharmaceutical microbiology laboratories | Lab practices, media, cultures |
Practical tips
- Note the TRS number and annex in your references; they are revised periodically.
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