Industry guidance
Parenteral Drug Association technical reports
Published by Parenteral Drug Association
Practical technical reports written by industry and regulatory experts. Not requirements, but highly respected references.
Why it matters to you: They explain how to design EM programmes, media fills, filtration and rapid methods in detail.
Key references for microbiology
| Reference | Topic | In short |
|---|---|---|
| TR 1 | Moist heat sterilisation validation | Cycles, F₀, BIs |
| TR 3 | Dry heat depyrogenation and sterilisation | Endotoxin challenge |
| TR 13 | Environmental monitoring programme | Locations, frequencies, trending |
| TR 22 | Process simulation (media fills) | Design and interpretation |
| TR 26 | Sterilising filtration of liquids | Validation and integrity testing |
| TR 33 | Alternative and rapid microbiological methods | Validation strategy |
| TR 70 | Cleaning and disinfection programmes | Agent selection and efficacy |
Practical tips
- Cite the report number and revision; explain your approach in your own words.
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