Chapter 1 revision and its 2 linked instruments
How to read this page
- First column: Chapter 1 revision. The others are every document linked to it.
- Scroll sideways if there are more columns than fit.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
| Chapter 1 revision | Chapter 1 (2013) | ICH Q10 | |
|---|---|---|---|
| Authority | European Commission | European Commission | ICH |
| Legal weight | GMP guide & annexes | GMP guide & annexes | Guidance & Q&A |
| Status | Draft | In force | Final |
| Last verified | Not yet | Not yet | Not yet |
| Summary | Draft revision of the EU GMP quality system chapter, recommended jointly by the GMP/GDP Inspectors Working Group and the PIC/S Committee to reflect ICH Q9(R1). Draft only. | The current EU GMP chapter on the pharmaceutical quality system. | ICH model for an effective quality management system for the pharmaceutical industry. |
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| Source | Official text Source: European Commission. Licensed under CC BY 4.0. | Official text Source: European Commission. Licensed under CC BY 4.0. | Official text Source: ICH. |
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.