APIC：起始物料（RSM）供应商第三方审计问答(中英文对照版).pdf

APIC 3rd party audit sub team for RSM suppliers QA documen t APIC ：起始物料（RSM ）供应商第三方审计问答 RSM=Registered Starting Materials （起始物料供应商 ） Question Answers 问答文件 Preamble 前言 Q: Is this guide mandatory /legally binding? 本指南是否强制/具有法规效力 ？ A: This guide is not mandatory neither legally binding, but it will support the user in evaluating the quality systems at the RSM supplier. If some of the requirements are not in place, a risk -based evaluation should be done to define the impact on the involved product. 本指南并非强制，也无法律效力，但它可以帮助使用方对起始物料（RSM ）供应商质量体系的评估。如果有些要求缺失， 应执行基于风险的评估确定对所涉及产品的影响。 Q: Do we need to audit RSM suppliers? 是否需要对起始物料（RSM ）供应商进行审计？ A: Auditingis not a legal requirement. However, it is important to evaluate the Quality System of the RSM supplier as part of the supplier qualification. There are different options to perform this (audit, questionnaire, …). The following criteria can be used (not limited): 审计并非法定要求。然而，评估起始物料（RSM ）供应商的质量体系作为供应商确认的一部分非常重要。有多种方法可 进行确认（审计、问卷……）。可使用以下标准（不限于） ：  complexity of the molecule  分子复杂程度  number of manufacturing steps between RSM and API  起始物料（RSM ）与API 之间生产步骤数量 1 / 6  knowledge of the supplier (e.g. past experience)  对供应商的了解（例如，过去的经验 ）  worldwide available or custom mad e  全球可及还是定制  continuous process or single cam paigns  连续加工还是单批生产  dedicated or multipurpose equipment  专用还是共用设备 The decision not to audit can be overruled at a later stage in function of specific events such important quality related issues, regulatory actions against the supplier . 做出不审计决定之后，后期如果发生具体事件如严重的质量问题、该供应商被官方采取强制措施，可否定之前的不审计 决定。 Q: Do audits have to be performed exclusively by members of the quality unit ? 审计是否只能由质量部门人员执行 ？ A: Quality