Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter

Regulatory Resource: Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) on 11 June 2009.
This annex is the result of the Q4B process for Sterility Test.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

Download Document: Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter

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