Transcription of 3.2 TEST FOR STERILITY - World Health Organization
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3.2 TEST FOR STERILITY - World Health Organization
Document FINAL March 2012 TEST FOR STERILITY Final text for revision of The International Pharmacopoeia This monograph was adopted at the Forty-sixth WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2011 for addition to the 4th Edition of the International Pharmacopoeia. The text, reproduced with the permission of the European Pharmacopoeia with appropriate editorial modifications, is one that has undergone pharmacopoeial harmonization by the Pharmacopoeial Discussion Group (PDG) of the European Pharmacopoeia ( ), Japanese Pharmacopoeia (JP) and United States Pharmacopeia (USP). This internationally harmonized test replaces the current method Test for STERILITY of non-injectable preparations and STERILITY testing of antibiotics. As a consequence, all references to and in monographs will be changed. In order to explain the clause unless otherwise justified and authorized mentioned in this text, the General Notices of the will be revised to include an explanatory note as follows: The expression unless otherwise justified and authorized means that the requirements have to be met or instructions to be followed, unless the relevant national or regional authority authorizes an exemption or modification, where justified in a particular case.
Document QAS/11.413 FINAL page 5 This method suitability is performed: a) when the test for sterility has to be carried out on a new product; b) whenever there is …
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