ICH guideline
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q7 |
|---|---|
| Title | Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 2000. This document is intended to provide guidance regarding Good Manufacturing Practice (GMP) for the manufacturing of Active Pharmaceutical Ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that… |
| File | ICH Q7 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- ICH Q7 Guideline Files published by ICH
- 1–9 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.