This revision to Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.变更理由: 自从附录15在2001年公布以来,生产和...
EUGMP指南附件15:确认和验证(中英文) 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 ...
欧盟GMP附录15 确认和验证培训
EU GMP 附录15：确认与验证(中英对照)
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 ...
[欧盟GMP] 附录15确认与验证.pdf,[欧盟GMP] 附录15确认与验证--第1页 确认与验证 Principle This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture
FinalVersionofAnnex15totheEUGuideto GoodManufacturingPractice Title:Qualificationandvalidation . Firstdiscussionindraftinggroup DiscussionattheworkingPartyonControlofMedicinesand Inspectionforreleaseforconsultation 16September1999 PharmaceuticalCommittee28September1999 ...
欧盟GMP 附录 15 确认和验证 ANNEX 15 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. Process Validation 工艺验证 6. Cleaning Validation 清洁验证 7. Change Control 变更控制 8. Revalidati...
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...
EU GMP Guide-Annex 15 Qualification 下载积分: 1000 内容提示: This document was prepared in February 2016, any content including links and quoted regulation may be out of date. Please refer to the appropriate source for the most recent information. We endeavour to keep an up-to-date record ...