eugmpannex11计算机控制系统+eugmpannex8原辅料 和包装材料的取样 预览说明:预览图片所展示的格式为文档的源格式展示,源文件没有水印,内 容可编辑和复制 附件11 COMPUTERISEDSYSTEMS计算机控制系统 Principle原则 Theintroductionofcomputerisedsystemsintosystemsof ...
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical Insp...
Validationaccording to paragraph 4 of annex 11 is required at least for spreadsheets thatcontain custom code (e.g. Visual Basic for applications). Formulas or othertypes of algorithm should be verified for correctness. 根据附录11第4段,对数据表格所需要进行的验证至少包括定制代码(例如visual Basic应用...
EU GMP guide annexes - Supplementary requirements: Annex 11 Computerised Systems 1. Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets? (H+V February 2011)Templates of Spreadsheets helps to avoid ...
Guidance on the role of the Qualified Person is elaborated in Annex 16. QP 的角色指南在附件 16 中说明。 2.7 The head of the Production Department generally has the following responsibilities: 生产部门负责人一般具有如下职责 i. To ensure that products are produced and stored according to the ...
Note2:Wherenationallegislationpermits,additionalguidanceregardingthepreparationofunlicensedsterilemedicinalproductsnormallyperformedbyhealthcareestablishmentsfordirectsupplytopatients,referencemaybemadetotheAnnex1:“Guidelinesonthestandardsrequiredforthesterilepreparationofmedicinalproducts”ofthePIC/Sguidetogoodpracticesforthepre...
place, suitable to protect the product and open components (e.g., containers) from contamination. The air speed range of 0.36 - 0.54 m/s is, as stated in the above paragraph itself, merely a guideline value that has been encountered in the pharmaceutical industry for decades. Annex 1,...
Since 30 June 2011 the industry has been to implement all requirements of Annex 11 "Computerised Systems" of the EU GMP Guideline. Within the context of the Conference on Computer Validation from 8 - 9 June 2011 in Mannheim, inspectors and industry experts have answered questions concerning the...
This technical interpretation focuses on some of the most important main changes of the revision 2022 of Annex 1 and also covers aspects that were already included in the previous version of this guideline and that repeatedly gave rise to questions. This technical interpretation is intended to refl...
EU-GMP-Part-II-Annexes-15.pdf EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 Working Party on Control of Medicines and Inspections Final Version of Annex 15 to the EU Guide to...