洛施德GMP咨询 - EU 人用药所用辅料的GMP水平确定用正式风险评估指南.pdf

Soltoris Management Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use 人用药所用辅料的GMP 水平确定用正式风险评估指南 (Text with EEA relevance) (2015/C 95/02) Introduction 概述 These guidelines are based on the fifth paragraph of Article 47 of Directive 2001/83/EC (1) . 这些指南是基于指令2001/83/EC(1)第47 条款第5 段落的。 According to the second paragraph of Article 46(f) of Directive 2001/83/EC, the manufacturing authorisation holder is required to ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice (GMP) is. The appropriate GMP for excipients of medicinal products for human use shall be ascertained on the basis of a formalised risk assessment in accordance with these guidelines. The risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The manufacturing authorisation holder shall ensure that the appropriate GMP ascertained is applied. The manufacturing authorisation holder shall document the measures taken. 根据指令2001/83/EC(1)第46(f)条款第2 段，生产许可持有人应保证辅料适用于其在药品中的用途，确认怎样 的GMP 是适当的。人药用辅料适当的GMP 应根据这些指南，基于正式的风险评估进行确定。风险评估应考 虑在其它适当质量体系下的要求，以及辅料来源和辅料用途，和之前的质量缺陷情况。生产许可持有人应保 证所确定的适当的GMP 是适用的。生产许可持有人应记录所采取的措施。 The excipient risk assessment/risk management procedure should be incorporated in the pharmaceutical quality system of the manufacturing authorisation holder. 辅料风险评估/风险管理程序应结合在生产许可持有人的药品质量体系中。 Manufacturing authorisation holders should have the risk assessment/management