公布详细指南的法律依据：指令2001/83/EC第47款关于人药共同体代码，和2001/82/EC第51款关于兽药共同体代码的要求。本文件为指令2003/94/EC中制订的人药GMP以及指令91/412/EEC兽药GMP原则和指南提供诠释。Status of the document: Revision 文件状态：修订 Reasons for changes: Since Annex 15 was published in ...
EUGMP指南附件15:确认和验证(中英文) EUROPEANCOMMISSION ENTERPRISEDIRECTORATE-GENERAL Singlemarket,regulatoryenvironment,industriesunderverticallegislation Pharmaceuticalsandcosmetics Brussels,July2001 WorkingPartyonControlofMedicinesandInspections FinalVersionofAnnex15totheEUGuideto ...
MKT_TMP200_01_r06 White paper: EU GMP Guide-Annex 15 Qualification & Validation draft released In February 2014, a draft of the revised Annex 15 was released by the European Commission (EC) for public comment. The draft version is based on an EMA Concept Paper, published in November 2012...
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 ...
EU GMP ANNEX 15 EUGMPANNEX15 Qualificationandvalidation TableofContents 1.QualificationandValidation2.PlanningforValidation3.Documentation4.Qualification5.ProcesssValidation6.CleaningValidation7.ChangeControl8.Revalidation9.Glossary QualificationandValidation Pri...
gmpannexesvalidationqualificationvmpfacilities EUROPEANCOMMISSION ENTERPRISEDIRECTORATE-GENERAL Singlemarket,regulatoryenvironment,industriesunderverticallegislation Pharmaceuticalsandcosmetics Brussels,July2001 WorkingPartyonControlofMedicinesandInspections FinalVersionofAnnex15totheEUGuideto GoodManufacturingPractice Title:Qualifi...
EU GMP ANNEX 15 Qualification and validation (July 2001) ACU 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. Docume...
EU GMP ANNEX 15 Qualification and validation (July 2001) ACU 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 ...
Reasons for changes: Update as per concept paper on revision of Annex 15. Summary of changes:This change to annex 15 takesinto account changes to othersections of the EU-GMP Guide Part I, Annex 11,ICH Q8, Q9, Q10 and Q11, QWPguidance on process validation and changes inmanufacturing techn...
The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle. Design qualification (DQ) (3.3) 3.3. The next element in the qualification of equipment, ...