MHRA第三国GMP检查 Workshop on GMP/Pharmacopoeia/APIs
Guidanceon responding to a GMP / GDP post inspection letter GMP/GDP检查后回复函指南 This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters. 本指南用于减少准备检查后回复函的工作负担。 This format is ...
the MHRA asks for specificinformation prior to a GMP Inspection while the Interim Compliance Report...
GMP/GDP检查后回复函指南 ThisguidehasbeenprovidedtoreducetheburdenwhenpreparingresponsestoPostInspectionLetters. 本指南用于减少准备检查后回复函的工作负担。 Thisformatisnotmandatory,butistheinspectorate’spreferredmethodforprovidingresponsesand shouldhelptoreducethetimetakentoreachacompliancedecisionaftertheinspection....
能够确保GVP检查成功的关键，更多信息可以在MHRA年度统计报告（Pharmacovigilance Inspection Metrics Report）...
Problems we see during inspection检查期间看到的问题 Withthe system系统方面 A strong principle of GMP is operating in a state of control. The PQS is the foundation which helps companies achieve this state. During inspection, we will look for evidence ...
GMP audit trails aremetadatathat are a record of GMP critical information (for example the change or deletion of GMP relevantdata). Where computerised systems are used to capture, process, report or storeraw dataelectronically, system design should always provide for the retention of full audit tr...
MHRA GMP Data Integrity Definitions and Guidance for Industry January 2015 MHRA GMP/20151 Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document provides MHRA guidance on GMP data integrity expectations for th...
Table 2: Chapters and Annexes Associated with MHRA Critical GMP Inspection Deficiencies in 2016 Figure 3:Distribution of these critical MHRA deficiencies Conclusions It is difficult to directly compare areas identified by the MHRA with those identified by the FDA, as the FDA does not categorize...
MHRAGMPDataIntegrity中英文.doc,MHRA GMP Data Integrity Definitions and Guidance for Industry January 2015 MHRA GMP 数据完整性定义和行业指导原则 1 月 2015 简述: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines