PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION
SCHEME
PI 038-2
1 January 2021
AIDE-MEMOIRE
备忘
ASSESSMENT OF QUALITY RISK
MANAGEMENT IMPLEMENTATION
质量风险管理实施的评估
Editor: PIC/S Secretariat
e-m a il:
web site:
Table of contents 目录
1.Document history 文件历史 (2)
2.Introduction 概述 (2)
3.Purpose 目的 (3)
4.Scope 范围 (3)
5.Aide-Memoire 备忘 (4)
6.Revision history 修订历史 (13)
1. Document history 文件历史
2. Introduction 概述
2.1 The holder of a manufacturing authorisation must manufacture medicinal products so
as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation (MA) and do not place patients at risk due to inadequate safety, quality or efficacy. The at
tainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a
comprehensively designed and correctly implemented system of Quality Assurance
(QA) incorporating Good Manufacturing Practice (GMP), and thus Quality Control (QC) and Quality Risk Management (QRM). It should be fully documented and its
effectiveness monitored.
生产许可证的持有人生产药品必须确保其适合其预期用途、符合销售许可证（MA）的要求，并且不会因安全性、质量或功效不足而使患者处于危险之中。达到这一质量目标是高级管理层的责任，需要公司许多不同部门和各个级别的员工、公司的供应商和分销商的参与和承诺。为了可靠地达到质量目标，必须有一个经过全面设计和正确实施的质量保证
（QA）系统，其中应包括良好生产规范（GMP），以及质量控制（QC）和质量风险管理（QRM）。应该对其进行充分记录并对其有效性进行监控。
2.2 Quality risk management  is a systematic process for the assessment,  control,
communication and review of risks to the quality of the medicinal product. It can be
applied both proactively and retrospectively. The quality risk management system
should ensure that:
质量风险管理是评估、控制、沟通和审查药品质量风险的系统过程。它既可以主动应用，也可以追溯应用。质量风险管理体系应确保：
- the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient;
- 对质量风险的评估是基于科学知识、工艺经验，并最终与患者保护相关的；
- the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.
- 质量风险管理过程的工作力度、正式程度和文件记录与风险水平相称
2.3 The harmonised tripartite quality guidelines ICH Q8(R1): Pharmaceutical Development,
ICH Q9: Quality Risk Management and ICH Q10: Pharmaceutical Quality System
form a set of three documents representing a new approach to pharmaceutical
development, manufacturing and distribution, often referred to as the paradigm shift
initiated by the ICH.
ICH Q8（R1）《药物开发》、ICH Q9《质量风险管理》和ICH Q10《药物质量体系》三份文件成为一套，代表了药物开发，生产和分销的新方法，通常称为 ICH发起的典型转变。
2.4 ICH Q9 was adopted in November 2005 as a step 4 document and consecutively on 14
February 2008 introduced as a voluntary Appendix 20 into the EU GMP Guide and on
15 January 2009 into the PIC/S GMP Guide. At the corresponding dates principles of
Quality Risk Management (QRM) were in addition introduced in Chapter 1 of both guides.
Chapter 2 in EU GMP Part II was updated with QRM requirements on 31 July 2010.
ICH Q9于2005年11月在第四阶段通过，并于2008年2月14日作为自愿性附录20引入欧盟GMP指南，并于2009年1月15日引入PIC / S GMP指南。同期，两本指南的第一章还引入了质量风险管理（QRM）原则。欧盟GMP第二部分的第二章已于2010年7月31日更新为QRM要求。
2.5  The primary objective for implementing ICH Q9 was to improve the implementation of
risk based approaches / the principles of quality risk management within the
pharmaceutical industry and regulatory environment.
实施ICH Q9的主要目标是改善制药行业和监管环境中基于风险的方法/质量风险管理原则的实施。
3. Purpose 目的
3.1 The purpose of this document is to assist GMP inspectors in the assessment of QRM
implementation in industry during regulatory inspections. Parts of this Aide-Memoire may also be useful (with suitable modification) during other GXP inspections where similar principles of QRM also apply.
本文件的目的是在监管检查期间协助GMP检查员评估行业中QRM的实施情况。在其他GXP检查中（也适用类似QRM的原则），本备忘录的部分内容也可能有用（进行适当的修改）。
3.2 This Aide-Memoire should also contribute to a harmonised approach for inspection of
QRM in industry between the different PIC/S Members.
本备忘录还应为不同的PIC / S成员之间的企业QRM检查提供一种统一的方法。
4. Scope 范围
4.1 At the time of issue, this document reflected the current state of the art. It is not
intended to be a barrier to technical innovation or the pursuit of excellence.
发行时，本文件反映了最新技术水平。它无意成为技术创新或追求卓越的障碍。
4.2 QRM aspects should be an integrated part of the planning and content of all GMP
inspections (including for final products as well as for active pharmaceutical
ingredients). The existence of this separate Aide-Memoire document does not suggest that specific inspections for QRM systems are performed.
QRM方面应成为所有GMP检查计划和内容（包括制剂和API）的组成部分。该单独的备忘录的存在并不意味着要对QRM系统进行专门的检查。
4.3 As Annex 20 represents a voluntary standard, this Aide-Memoire relies mainly on the
corresponding mandatory articles of Chapter 1 and Annex 15 of the PIC/S GMP
Guide.
由于附件20是自愿性标准，因此本备忘录主要依据《 PIC / S GMP指南》第1章和附件15中的相应强制性条款。
5. Aide-Memoire备忘
5.1 The Aide-Memoire should be used with the following general comments: 本备忘使用时应
考虑以下通用建议：
-
During an inspection dedicated time is required to be allocated to review the QRM system.
documented翻译- 在检查期间，要求安排有专门的时间审核QRM系统
- During a general inspection the inspector should be able to review how the company has integrated QRM without allocating further specific time to the QRM aspects of the inspection.
- 在一般检查期间，不需要安排单独时间对QRM进行检查，但检查员应能够审核公司是如何整合QRM的
- References to the GMP Guide given in the row “Reference” refer to the PIC/S GMP Guide Part I.
- 参考“引用”栏中引用的PIC GMP 指南第I部分给定的GMP指南