Compare ICH Q10 and Annex 15
How to read this page
- How they are linked says why these two documents are connected. Links explained
- Side by side places facts from each record together, so you can see status, weight and dates at a glance.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
How they are linked
- ICH Q10 is related to Annex 15 · Source Unverified link
Side by side
| ICH Q10 | Annex 15 | |
|---|---|---|
| Authority | ICH | European Commission |
| Legal weight | Guidance & Q&A | GMP guide & annexes |
| Status | Final | In force |
| Last verified | Not yet | Not yet |
| Summary | ICH model for an effective quality management system for the pharmaceutical industry. | The EU GMP annex on qualification and validation. |
| Lifecycle |
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| Source | Official text Source: ICH. | Official text Source: European Commission. Licensed under CC BY 4.0. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.