ICH Q4B Annex 8 Sterility test - Scientific guideline
HumanScientific guidelines
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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.
Keywords: Sterility test, pharmacopoeia