One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th2016. Please find here an analysis of this draft. 2015年底,WHO采纳了其最近技术标准附录7。附录7为非无菌工艺验证提供了支持。现在,WHO指南有了进一步...
SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/13.527: 37 PROPOSAL FOR REVISION OF THESUPPLEMENTARY GUIDELINE ON 38 GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7: NON-STERILE 39 PROCESS VALIDATION 40 41 42 43 Need for revision of published good manufacturing ...
documentwascirculatedforcommentinearly2013.Thefocus,atthattime,was revisionoftheappendixonNon-sterileprocessvalidation(Appendix7)(2),which hadbeenrevisedandwasadoptedbytheECSPPatitsForty-ninthmeetingin October2014(3). Theoverarchingtextpresentedinthisannexconstitutesthegeneral ...
2.2 This guideline should be applied when transferring the technology of processes and procedures relating to active pharmaceutical ingredients (APIs), in-process bulk materials, finished pharmaceutical products (FPPs), process validation, cleaning procedure development and validation and analytical...
The Expert Committee adopted the Pro duction of water for injection by means other than distillation guideline and recommended that it should also be integrated into WHO’s existing guideline on Good manufacturing practices: water for pharmaceutical use . 2019 年初, WHO 秘书处委托起草了一份关于...
canbe,forexample,fromdrugdiscoverytoproductdevelopment; toclinicaltrials;ortofull-scalecommercializationand commercialbatchmanufacturing;cleaningandvalidation. 在获得上市许可之前,生产和控制程序、验证以及其它相关活动可以 从一个场所转移到另一场所。在某些情况下,这种转移是在监管机构 ...
WHO《制药用水GMP指南》-2020草案(中英文对照版)Working document QAS/20.842 工作文件QAS/20.842 May 2020 二零二零年五月DRAFT WORKING DOCUMENT FOR COMMENTS:征求意见草案:Good manufacturing practices:优良制造规范（GMP）:water for pharmaceutical use 制药用水 1 / 25 ...
2.2 This guideline should be applied when transferring the technology of processes and procedures relating to active pharmaceutical ingredients (APIs), in-process bulk materials, finished pharmaceutical products (FPPs), process validation, cleaning procedure development and validation and analytical proced...
2.2 This guideline should be applied when transferring the technology of processes and procedures relating to active pharmaceutical ingredients (APIs), in-process bulk materials, finished pharmaceutical products (FPPs), process validation, ...
3.6. This guideis not intended to define registration requirements or modify pharmacopoeialrequirements or other guideline recommendations. For details on processdevelopment, it is recommended that other guidelines, such as those publishedby The International Council for Harmonisation of Technical Requirements...