ICH guideline
ICH Q7 Q&As: Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q7 Q&As |
|---|---|
| Title | Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The document was finalised under Step 4 in June 2015.Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 showed that uncertainties related to the interpretation of some sections exist.Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are… |
| File | ICH Q7 Q&As Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- ICH Q7 Q&As Step 4 Presentation Files published by ICH
- None FDA guidance documents based on this guideline
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About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.