6.CleaningValidation清洁验证7 7.ChangeControl变更控制8 8.Revalidation再验证9 9.Glossary术语10 QUALIFICATIONANDVALIDATION确认和验证 Principle原则 1.ThisAnnexdescribestheprinciplesofqualificationandvalidationwhichareapplicabletothe manufactureofmedicinalproducts.ItisarequirementofGMPthatmanufacturersidentifywhat ...
EU GMP ANNEX 15 EUGMPANNEX15 Qualificationandvalidation TableofContents 1.QualificationandValidation2.PlanningforValidation3.Documentation4.Qualification5.ProcesssValidation6.CleaningValidation7.ChangeControl8.Revalidation9.Glossary QualificationandValidation Pri...
This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant cha...
This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control...
EU GMP 附录15：确认与验证(中英对照)
QUALIFICATION AND VALIDATION确认和变更 Principle原则 This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. It is a GMP requirement that manufacturer’s control the critica...
内容提示: ANNEX 15 附件 15 Qualification and Validation 确认和验证 Table of Contents 目录 1. Qualification and Validation 确认和验证 2. Planning for Validation 验证计划 3. Documentation 文件 4. Qualification 确认 5. Processs Validation. 工艺验证 6. Cleaning Validation 清洁验证 7. Change Control ...
验证gmp确认validationqualificationannex EUGMPannex15QualificationandValidation(draft)Brussels,6February2014SANCO/TSE/Thereceivedcontributionstogetherwiththeidentityofcontributorswillbemadepubliclyavailable,unlessthecontributorobjectstopublicationofhisorherpersonaldataonthegroundsthatsuchpublicationwouldharmhisorherlegitimateint...
EU GMP 附录15:确认与验证-英文_药学_医药卫生_专业资料。Principle This Annex describes the principles of qualification and validation which are applicable t Principle This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and ...
附录验证gmp确认中英文武晋娴 翻译:武晋娴 校对:陈国笋 1 / 22 此译文仅供学习之用,如有翻译不当,可参考英文原文。 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use 人用与兽用药品的生产质量管理规范的欧盟指南 Annex 15: Qualification and Validation 附录15...