GMP-Advisor课件.pdf

The GMP Questions Answers Guide Version 1.0 GMP Advisor The GMP Questions Answers Guide Version 01 of April 2014 Page 1 of 152 The GMP Questions Answers Guide Version 1.0 About this document Searching for concrete answers to GMP questions is a time-consuming activity. This document is intended to provide a single source of information. We have summarized GMP questions and answers from Regulators around the world. In addition to EMA, FDA, Health Canada, MHRA (UK), TGA (Australia) and ICH we have also used QAs from ECA. The subject index contains some of the “GMP Key Words” and allows to find QAs addressing the relevant topic. It is the intension to update this comprehensive collection and to also add new QAs once they are available. Edited by ECA Academy P.O. Box 10 21 68 69011 Heidelberg, Germany info@ While every effort has been made to assure the accuracy of the contents of this brochure, ECA Academy cannot be held liable for any errors or omissions. Page 2 of 152 The GMP Questions Answers Guide Version 1.0 Table of Contents 1. General GMPs 5 1.1 EMA Europe 5 1.1.1 General 5 1.1.2 EU GMP Annex 1 Sterile Products 7 1.1.3 EU GMP Annex 6: Manufacture of medicinal gases 9 1.1.4 EU GMP Annex 8: Sampling 11 1.1.5 EU GMP Annex 11: Computerised systems 13 1.1.6 EU GMP Annex 16 QP and Batch Release 15 1.1.7 EU GMP Annex 19 Reference Standards 15 1.1.8 Impurities 16 1.2 MHRA (Europe/UK) 19 1.2