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News about GMP/cGMP
FDA: New ICH Q4B Annexes 5, 8, 11 &12
The annexes 8, 11 & 12 of the ICH QB4 document "Evaluation and Recommendation of Pharmacopoeial Texts used in the ICH Regions" are not really new. They were already published by the ICH at its website.
- Q4B Annex 5: Disintegration Test General Chapter was published at June 10, 2009
- Q4B Annex 8: Sterility Test General Chapter was published at June 11, 2009
- Q4B Annex 11: Capillary Electrophoresis General Chapter was published at October 29, 2009
- Q4B Annex 12: Analytical Sieving General Chapter was published at October 29, 2009
With the US implementation they were now published as Guidance for Industry at the FDA website
Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
- Annex 5: Disintegration Test General Chapter was published at December 22, 2009
- Annex 8: Sterility Test General Chapter was published at December 22, 2009
- Annex 11: Capillary Electrophoresis General Chapter was published at December 16, 2009
- Annex 12: Analytical Sieving General Chapter was published at December 16, 2009
Source: FDA News website & ICH Quality Guidelines