ICH Q4B Annex 8 Sterility test
|Current effective version|
|Keywords||Sterility test, pharmacopoeia|
This annex is the result of the Q4B process for the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial sterility testing procedures by regulatory authorities in the ICH regions.
In operation: 01/12/2009–present