11.4. Where activities are outsourced tocontract facilities, the contract must then clearly state, inter alia, theresponsibilities of each party, compliance with GMP or of this guideline, andthat the product(s) to be manufactured or controlled are intended for use inclinical trials. Close cooperat...
Where agents are used for sanitization, their removal must be proven. 4.3.7 The following controls should be considered: • the maintenance of water flow at all times, in order to prevent water from stagnating; • control of temperature in the system by heat exchangers or plant room ...
对于非SRA流程进行的申报,WHO会对生产工厂(原料及制剂)进行GMP核查,临床机构进行GCP核查,若进行SRA流程申报,则豁免GMP和GCP核查。WHO会在进行核查之前的6个月内发出核查通知, 检查完成后30天内出具检查报告;申请人需在30天内提交整改报告;若WHO认为整改报告不充分,可能会在60天再进行一次核查(follow-up inspection)...
鉴于最近医药产品治疗COVID-19的前所未有的快速发展的需要,世界卫生组织(WHO)预确认检查服务团队(PQT INS)提出了发展的紧迫性良好生产规范(GMP)文本解决发展的生产批次,为上市批准和医药产品预确认而提交的产品申请(档案)中的中试批次和序列稳定性数据。 There are currently no regulatory guidelines whichaddress this...
WHO TRS986 附录 2:WHO 药品 GMP 总则, 2014.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and esse
需要金币:*** 金币(10金币=人民币1元) WHO医用气体GMP指南(2021草案).pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Working document QAS/21.875 February 2021 DRAFT WORKING DOCUMENT FOR COMMENTS: Good manufacturing practices for medical gases Please send your comments to Dr Sabine...
2.qualitymustbedesignedandbuiltintotheproduct; 3.qualitycannotbeinspectedortestedintotheproduct; 4.principlesofqualityriskmanagement(8)shouldbeapplied indeterminingtheneed,scopeandextentofqualificationand validation; 5.ongoingreviewshouldtakeplace,toensurethatthequalifiedor ...
11.4. Where activities are outsourced tocontract facilities, the contract must then clearly state, inter alia, theresponsibilities of each party, compliance with GMP or of this guideline, andthat the product(s) to be manufactured...
3.7. This guide does not affect the ability of the responsible regulatory agency to establish specific registration or filing requirements. All commitments in registration and filing documents must be met. This document provides information ...
1WorldHealthOrganization世界卫生组织WHOTechnicalReportSeries,No.908,2023WHO技术报告系列第908号,2023年Annex6附录6GuidanceonGoodManufacturingPractices(GMP):inspectionreportGMP检查报告指南Whenasiteatwhichpharmaceuticalproductsaremanufacturedisinspected,theinspector(s)responsiblemustdrawupareportcontainingtheitemslistedbelow...