权威医学用药书籍速查系统

4. CONSIDERATIONS FOR IMPLEMENTATION

When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeia texts that are referenced in Section 2.1 of this annex , any change notification , variation .And/or prior approval procedures should be handled in accordance with established regiona regulatory mechanisms pertaining to compendial changes .In accordance with the conditions set out in this annex , as fulfilling the requirements for compliance with the Ph . Eur . Chapter , Sterility : 2.6.1 . , on the basis of the declaration of interchangeability made above .

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——《2011药品注册的国际技术要求.质量部分》
书名:《2011药品注册的国际技术要求.质量部分》
栏目:2011药品注册的国际技术要求.质量部分 > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON STERILITY TEST GENERAL CHAPTER Q4B ANNEX 8(R1) > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON STERILITY TEST GENERAL CHAPTER Q4B
作者:美国ICH指导委员会 周海钧
参编:王执,王知坚,匡荣,李洋,张洁
页码:357-358
版本:1
出版时间:2011-01-01
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