11个关于原辅料、包材放行检验的相关问答

1Questions：What is meant by ‘full analysis’[ICHQ7, Section 7.31] on batches of raw materials to qualify a supplier?Answers：A ‘full analysis’ should include all tests specified by the user of the raw material in the regulatory filing.In cases where no filing is required, the full analysis should include tests in other formalwritten specifications issued by the user of the raw material [ICH Q7, 7.31]. A raw material supplier’s Certificate of Analysis (CoA) may not necessarily align with the user’s specifications.问：对原料各批进行“全检”【ICH Q7，第7.31部分】以对供应商进行确认是什么意思？答：“全检”包括注册文件里载明的该原料的所有检测项目。如果不需要注册，则全检应包括其它由原料使用者签发的正式书面质量标准里的所有分析项目【ICH Q7第7.31部分】。一个原料 ………………………………