New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities 基于ICMRA草案的GMP检查认可的新PIC / S指南,...
强化供应链韧性，并评估对少数制造商和工厂依赖所带来的长期风险Promoting supply chain resilience and addressing long-term risks stemming from over-reliance on a limited number of manufacturers and sitesIdentify suitable locations for collaborative oversight among member states and strategic partners.确定成员国...
该指南概述了海外设施GMP合规性的评估流程,以确定可以通过其他NCA的活动确认和确保可接受的GMP合规水平的情况,而无需现场检查。 GMP INSPECTION RELIANCE GMP检查的依赖性 1.DOCUMENT HISTORY文档历史记录 2.INTRODUCTION引言 3.PURPOSE宗旨 4.SCOPE范围 5.PROCESS过程 5.1 Introduction引言 5.2 Establishing country reli...
•Reliance on participating authorities’ inspections should be preferred over sole inspections so that sole inspections are deferred or postponed based on another participating authorities’ inspection. •参与药监方应优先依赖其它方的检查,而不是独立检查,根据另一参与药监的检查结果取消或推迟单独检查。 ...
Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test. Processing 82. The efficacy of any new procedure should be validated, and the validation verified at scheduled intervals based on 咨询电话:400-8770626 8/160 北京市朝阳区朝阳...
Denigan-Macauley raised concerns about differences between US and foreign inspections, including the practice of providing advance notice to foreign facilities, which may allow for corrective action prior to inspection. She also noted the reliance on interpreters provided by the foreign establishment, whi...
It is recognised that the QP will need to rely on the pharmaceutical quality system and the QP should have on-going assurance that this reliance is well founded. 1.7.1 All activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the ...
2.7 The manufacturer should take all steps and precautions necessary to assure the sterility of the products manufactured within its facilities. Sole reliance for sterility or other quality aspects should not be placed on any terminal process or finished product test. ...
up on remote inspections. Its aim is to establish uniformity among inspectorates in carrying out these inspections. This consistency will enhance communication between agencies, promote reliance on Good Manufacturing Practice (GMP) inspections, and lead to more efficient use of global inspection ...
EU GMP 附录21:进口医药产品-2022年-英文.pdf,EUROPEAN COMMISSION Brussels, 16.2.2022 C(2022) 843 final GUIDELINES The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products fo