PICS GMP中文版(第一部分)西藥藥品優良製造規範 （第一部）PIC/S：Guide to Good Manufacturing Practice for Medicinal Products （Part I）PE009-13 (1 January 2017)© PIC/S January 2017
质量管理、良好制造规范(GMP)和质量风险管理三者是相互关联的。描述它们是为了 强调它们的关系,以及它们对药品生产和控制的重要性。 翻 PHARMACEUTICAL QUALITY SYSTEM 1 药品质量体系 (1 National requirements require manufacturers to establish and implement an effective pharmaceutical quality assurance system. The ...
Revision history 版本历史 PIC/S GUIDANCE/GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS (draft) Page 4 / 56 PIC/S 在受法规约束的 GMP/GDP 环境下数据管理和完整性优良规范(草案) 翻译:Julia 1 DOCUMENT HISTORY 文件历史 Draft 1 of PI 041-1 presented to the ...
38 对于我来说，你发英文的毫无意义 你建议的很好，这辈子我都干不了QA的活了
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 041-1 1 July 2021 PIC/S GUIDANCE GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS © PIC/S 2021 Reproduction prohibited for commercial purposes. Reproduction for internal use is authori...
current PIC/S GMP Guide.2.1.2 The purpose of this document is to provide guidance for GMP inspectors in reviewing the issues covered to use for training purposes and in preparation for inspections.2.1 本文件的目的 2.1.1 这些建议性文件的主题涉及的是那些审计人员和制药企业都认为需要对现行PIC...
2PIC/SPE009GuidetoGoodManufactingPracticeforMedicinalProducts,specificallyPartIchapters4,5,6,PartIIchapters5,6&Annex11PIC/SPE009药品GMP指南,具体为第一部分第4、5、6章,第二部分第5、6章和附录11.3PIC/SPE011GuidetoGoodDistributionPracticeforMedicinalProducts,specificallysections3,4,5&6PIC/SPE011药品GDP...
PICS 对无菌药品生产重大变化的解释(032-2)
欧盟GMP保留了《药品检验公约》第1条对药品(在本指南中称为“药品”)的定义; references to the EU Directives, as well as to MRAs, have been deleted; 欧盟指令和MRA的引用已删除; the expression "authorised person" (see Glossary) is used in the PIC/S Guide while the expression ...
也被称为性能确认 (PQ, Performance Qualification) 2.4 Terminology 2.4.1 Terminology used in the four Recommendation documents which is not defined in the current glossary of the PIC/S Guide to GMP, is presented at the end of this document. 2.4.2 It is worth commenting on the ...