ICHQ7问答 Q7 Questions and Answers 问答
ICH Q7还描述以适用于临床试验用API(第19部分),以及细胞培养/发酵(第18部分)生产的GMP原则。 Q7 Questions and Answers问答 # Date of Approval 批准日期 Questions 问 Answers 答 1. INTRODUCTION – SCOPE概述---范围 1.1 June 2015 Should GMP according to ICH Q7 be applied for manufacturing Steps before...
Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 原料药生产的GMP指南的问与答 Step 5 2015/6/10 前言 自从ICH Q7指南定稿,在全球实施中,有不少要求期望对一些内容的不确定性进行澄清。本问答文件就是为了对这些咨询做出回应。 ICH Q7文件应作为整体阅读,而不管所实...
Q7- IWG_QA_v5_0_14Apr2015_FINAL_for_publication_17June2015.pdf 全文翻译：http://zhuyujiao1972.blog.163.com/blog/static/986947272015643227155 Q7 Implementation Working Group ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers ...
Q7 Questions and Answers 问答 Date of App rova l 批准日 期 Questions 问 Answers 答 1. INTRODUCTION -SCOPE 概述---范围 1. 1 1. 2 June 2015 June 2015 Should GMP accordi ng to ICH Q7 be app lied for manu facturi ng Steps before the defi ned ?API starti ng materia l i.e., Ste...
参考文献:Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers 作者精彩原创集锦 1、创新药研发中原料药工艺与沟通交流常见难点 2、创新药研发中「制剂工」常见难点 3、创新药研发中「变更...
Q7A专家问答中英对照版第1页,共228页仅供个人参考,不得用于商业用途。如需要免费电子版本,请和chank(chank@etang)联系。Q7A:QuestionsandAnswersQ7A问答1TableofContents目录Guidanceforindustry:Q7AGoodManufacturingPracticeGuidanceforActivePharmaceuticalIngredients工业指南:Q7A原料药质量管理规范指南 Section1A:Backgroundan...
申请人应在申请中提供有关上游流程的信息,以证明拟议的起始材料的合理性,包括持续存在的杂质控制策略。 参考文献:Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers
an alternative means if you can show that the alternative means givesyou an acceptable level of quality. Q7A does not specifically recommend a uselog. So one could work through the batch records, in a reasonable period of time,to find the answers to any questions on equipment cleaning and ...
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ___ Questions and Answers Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)...