欧盟人用药所用辅料的GMP水平确定用正式风险评估指南

huigenghao

Guidelines

on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use

(2015/C 95/02)

Introduction

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.

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 documentation for appropriate GMP for excipients available on site for review by GMP inspectors. Consideration should be given to sharing relevant information from the risk assessment with the excipient manufacturer to facilitate continuous improvement.

自2016年3月21日起，人用上市药品用的辅料应实施这些指南中要求的风险评估。

CHAPTER 1 SCOPE

这些指南适用于风险评估，来评价应用适当的GMP于人用药所用辅料管理。根据指令2001/83/EC的第1(3b)条款，一种辅料是药品中除活性物质和包装材料外任意的组成部分。

These guidelines do not cover substances added to stabilise active substances that cannot exist on their own.

第2章 基于辅料类型和用途的适当的GMP决策

In EudraLex Volume 4, Guidelines for Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part III: GMP related documents, ICH guideline Q9 on Quality Risk Management (ICH Q9), principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality, including excipients, can be found.

这些质量风险管理原则应用于评估每种辅料所呈现的质量、安全和功能方面的风险

For each excipient from each manufacturer used, the manufacturing authorisation holder should identify the risks presented to the quality, safety and function of each excipient from its source — be that animal, mineral, vegetable, synthetic, etc. — through to its incorporation in the finished pharmaceutical dose form. Areas for consideration should include, but are not limited to:

另外，关于每种辅料的使用和功能，生产许可持有人应考虑：

在建立和记录辅料的风险概况之后，生产许可持有人应建立和记录欧盟药品法第4卷的要素，这些要素应是公司认为其为控制和维护辅料质量所必须的，例如附录1和/或附录2，第2部分用作起始物料的活性物质的基本要求。

These elements will vary depending on the source, the supply chain and the subsequent use of the excipient, but as a minimum the following high level GMP elements should be considered by the manufacturing authorisation holder:

第3章 确定辅料生产的风险概况

After determination of the appropriate GMP, a gap analysis of the required GMP against the activities and capabilities of the excipient manufacturer should be performed.

用以支持差距分析的数据/证据应通过审计获得，或从辅料生产商处收到的信息获得。

Certification of quality systems and/or GMP held by the excipient manufacturer and the standards against which these have been granted should be considered as such certification may fulfil the requirements.

所识别出的GMP要求和辅料生产商的活动与能力之间的差距应进行记录。另外，生产许可持有人应实施进一步风险评估，以决定该辅料生产商的风险概况，例如，低风险、中等风险或高风险。欧盟药品法第4卷，第3部分，ICHQ9应用于此目的。质量风险管理工具，例如列于其中的那些----HACCP等-----应用于此。

The manufacturing authorisation holder should have a series of strategies ranging from acceptance through control to unacceptable for the different risk profiles and based on these a control strategy, e.g. audit, document retrieval and testing, should be established.

第4章 适当GMP的申请确认

Once the appropriate GMP for the excipient and the risk profile of the excipient manufacturer have been defined, ongoing risk review should be performed through mechanisms such as:

基于风险审核的结果，应对已建立的控制策略进行审核，并在必要时进行修订。

本文来源：Julia/Candy。

syhorchid

谢谢分享

一沙一叶

辅料生产也要风评起来