重磅！PIC/S发布《质量风险管理实施的评估》（中英文对照翻译）

来自：PIC/S JULIA法规翻译

翻译：JULIA

原文官网下载https://picscheme.org/docview/3823

中英文下载

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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

© PIC/S 2021

Reproduction prohibited for commercial purposes.

Reproduction for internal use is authorised, provided that the source is acknowledged.

Editor:PIC/S Secretariat

e-mail:info@picscheme.org

web site:http://www.picscheme.org

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

Document history 文件历史

Adoption by Committee

16 March 2012

委员会采纳

2012-03-16

Entry into force

2 April 2012

生效

2012-04-02

Introduction 概述

    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 attainment 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。

    1. 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

    1. 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。

    1. 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。

    1. 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。

Purpose 目的

    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）。

    1. 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。

Scope 范围

    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。

    1. 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。

    1. 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。

Aide-Memoire 备忘

    • During an inspection dedicated time is required to be allocated to review the QRM system.

    • 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

    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：

1. Overall Systems

整体系统

The purpose of this portion of the Aide-Memoire is to ascertain the extent to which a company can demonstrate that it has a systematic approach to the integration of the principles of QRM into its operational systems, and its endorsement and active support by senior management.

本备忘的本部分意在确定公司能证明其具备系统性的方法将 QRM 原则结合至其运营系统中的程度，并得到高级管理层的背书和主动支持。

QRM should not be an isolated System of QA, it should be fully embedded into the QA or QM- System. QRM 不应作为独立于 QA 的系统，它应该全面嵌入 QA 或 QM 系统。

The QRM process normally consists of several steps including:

QRM 流程一般包括几个步骤：

  • Process mapping identifying all inputs, outputs and existing control measures;

  • 流程作图识别所有输入、输出和现有控制措施

  • Risk Assessment (incl. risk- identification, risk-analysis and evaluation);

  • 风险评估（包括风险识别、风险分析和评估）

  • Risk Control (including risk reduction and risk Acceptance);

  • 风险控制（包括风险降低和风险接受）

  • Communication (i.e. the residual risk should be communicated to the regulators and customers);

  • 沟通（即残留风险应与监管方和客户进行沟通）

  • Regular Review of the risks.

  • 定期审核风险

These questions seek to gather evidence that:

这些问题要收集证据证明：

  • The use of QRM is planned;

  • QRM 使用经过计划

  • The key elements of the QRM program are clearly defined and documented;

  • QRM 计划的关键要素有清楚规定和记录

  • Senior Management provides visible support to QRM;

  • 高级管理层为 QRM 提供了可见支持

  • Key outcomes of QRM are communicated to and acted upon by Senior Management.

  • QRM 的关键结果会沟通给高级管理层并由其做出反应

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Crucial indicators and related questions

关键指标和相关问题

Reference

引用

1.1

Is there a high level controlled document describing the company’s policies and approach to QRM?

GMP Guide 1 Principle

是否一份高度受控的文件说明公司的 QRM 方针和方法？

GMP 指南 1 原则

1.2

Do the key attributes of this document describe how:

本文件的关键属性是否描述了如何：

1.3

-What evidence is there that senior management shows commitment to the programme?

ICH Q10 & GMP

Guide 1 Principle

-有什么证据表明高级管理层对该计划有承诺？

ICH Q10&GMP 指南 1 原则

1.4

-Responsibilities and functions of key individuals involved in the QRM programme are defined?

GMP Guide: 1 Principle & 1.4(v) & 2

-是否规定参与 QRM 计划的关键人员的职责和职能？

GMP 指南 1 原则&1.4&2

1.5

-The scope, planning and scheduling of QRM activities are organised?

GMP Guide 1.12

-QRM 活动的范围、规划和时间计划是否有组织？

GMP 指南 1.12

1.6

-QRM activities are monitored, evaluated and reviewed for effectiveness?

GMP Guide 1.12

-QRM 活动有效性是否受到监测、评估和审核？

GMP 指南 1.12

1.7

-QRM activities are authorised and communicated?

GMP Guide 1.12

-QRM 活动是否有批准和沟通？

GMP 指南 1.12

1.8

-The QRM principles are incorporated into GMP training?

GMP Guide 2 2.11

-QRM 原则是否结合至 GMP 培训中？

GMP 指南 2.2.11

1.9

-The training requirements for staff directly involved in QRM activities are determined and delivered?

GMP Guide 2 2.10 to

2.14

-是否确定并传达了参与 QRM 活动的员工培训需求？

GMP 指南 2.2.10 至 2.14

1.10

-The QRM methodologies are selected and applied?

GMP Guide 1.12

-是否选择并应用了 QRM 方法学？

GMP 指南 1.12

1.11

-The QRM is integrated within the quality system including management of changes to the program?

GMP Guide 1 Principle

-QRM 是否整合到质量体系内包括程序变更管理？

GMP 指南 1 原则

1.12

Are systems in place to ensure risks to the quality of the medicinal product are:

  • Assessed?

  • Controlled?

  • Communicated?

  • Reviewed as part of the routine Quality Management Review Process?

GMP Guide 1.12

是否有系统确保药品质量风险受到：

  • 评估？

  • 控制？

  • 沟通？

  • 作为日常质量管理审评流程的一部分进行审核？

GMP 指南 1.12

2. Expectations on how QRM should be implemented

QRM 应如何实施的期望

The level of effort, formality and documentation of the QRM-process should be commensurate with the level of risk. Expectations on the formality and extent of the application of QRM principles during the Inspection will depend upon circumstances and the operations being examined. The conclusions of the risk management process should be justified and documented.

QRM 流程的工作力度、正式程度和文件记录应与风险水平相称。检查期间对 QRM 原则应用的正式程度和深度期望取决于环境和所检查的操作。风险管理流程的结论应经过论证并有文件记录。

This portion of the Aide-Memoire is intended to gather evidence that the following general principles are applied:

本备忘的本部分意在采集以下通则适用的证据：

  • The basis of any valuable Risk Assessment is scientific knowledge and experience with the process being assessed. The basis for the evaluation of the identified and analysed risks is defined by the risk to the patient:

  • 所有有价值的风险评估的基础都是被评估工艺的科学知识和经验。对被识别和分析的风险进行评估的基础是由患者风险所定义的：

    • Evidence for effectiveness of risk mitigation should be available;

    • 应有风险缓解的有效性证据

    • Where specific risk elements are discounted this should be supported by appropriate rationale;

    • 如果忽略了特定的风险要素，则应有恰当的理由支持

    • Evidence supports the decisions made.

    • 支持所做决策的证据

  • There is a risk that inappropriate conclusions may be drawn should assessments be based upon:

  • 如果评估基于以下内容，则可能得出不当结论：

    • Unjustified assumptions;

    • 未经论证的假设

    • Incomplete identification of risk(s) or inadequate information;

    • 风险识别不完整或信息不充分

    • Lack of relevant experience of the process being assessed and/or inappropriate use of the risk assessment tools.

    • 缺乏所评估工艺的相关经验，和/或不当使用风险评估工具

  • The use of external resource in assessment can be helpful however:

  • 在评估中使用外部资源可能会有所帮助，但是

    • Sole reliance on these may result in inappropriate conclusions or a lack of ownership of the assessment.

    • 仅依赖于此可能会导致不当结论，或缺乏评估所有权

    • Any outsourced elements of QRM should be closely evaluated by the inspector and companies discouraged from completely outsourcing their QRM efforts to consultants.

    • 检查员应仔细评估所有外包QRM 要素，不鼓励公司将其 QRM 工作全部外包给顾问

    • There should always be adequate involvement and ownership of risk assessments by staff responsible and accountable for the activities being assessed.

    • 应始终对负责评估活动的人员负责，并充分承担风险评估的责任

Inspectors should be cautious when reviewing assessments which include other business related risks (e.g. environmental, occupational health & safety) in addition to quality risk assessments. As whilst these factors are important in a holistic sense there is a danger that they may compromise quality.

除了质量风险评估以外，检查员应谨慎审核包括含有其它风险相关业务的评估（例如，环境、职业健   康&安全）。尽管这些因素在整体意义上很重要，但存在危害质量的危险。

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Crucial indicators and related questions

关键指标和相关问题

Reference

引用

2.1

Does the Quality Risk Management System ensure that the assessment of the risk to quality:

质量风险管理系统是否确保评估质量风险：

2.2

  • Is based on a systematic identification of risks?

  • Identifies all reasonably expected risks?

GMP Guide 1.12

  • 是否基于系统性的风险识别？

  • 识别了所有合理预期的风险？

GMP 指南 1.12

2.3

- Takes account of current scientific knowledge and any risk elements discounted are done so from a basis of scientific knowledge and evidence?

GMP Guide 1.13

-是否考虑当前的科学知识和所有忽略的风险要素均是基于科学知识和证据？

GMP 指南 1.13

2.4

-Is conducted in a systematic manner and supported by appropriate evidence for risk mitigation?

GMP Guide: 1.12 & 1.13

-风险缓解是否以系统性方式执行，并有恰当证据支持？

GMP 指南 1.12&1.13

2.5

  • Takes account of experience of the process under assessment?

  • Does not include any unjustified assumptions?

GMP Guide 1.13

  • 是否考虑了被评估工艺的经验？

  • 是否未包括任何未经论证的假设？

GMP 指南 1.13

2.6

-Is performed by experienced staff trained in the use of relevant risk assessment tools?

GMP Guide 1.13

-是否由经过培训的有经验的员工使用相关的风险评估工具执行评估？

GMP 指南 1.13

2.7

-Is ultimately linked to the protection of the patient?

GMP Guide 1.13

-最终是否关联至患者保护？

GMP 指南 1.13

2.8

-Ensures that key steps and decisions are documented with a formality that is commensurate with the level of risk?

GMP Guide 1.13

-确保关键步骤和决策均有与风险水平相称的正式程度的文件记录？

GMP 指南 1.13

2.9

  • Are periodically reviewed for currency and effectiveness?

  • Is conducted proactively, retrospectively and reactively as appropriate?

GMP Guide 1.12

  • 是否对适用性和有效性进行定期审核？

  • 预先、回顾性还是被动（适当时）执行？

GMP 指南 1.12

2.10

  • Ensures where assessments are revised, the changes are clearly visible and tracked?

  • Has any involvement of external resources been in a facilitating/advising mode rather than doing?

  • Has the correct balance of ownership by local knowledgeable staff been maintained?

  • Are there agreements in place and has the competence of the contract acceptor been adequately assessed by the company where elements of the QRM has been performed by an external party?

GMP Guide 1.12

-确保如果对评估进行了修订，则有变更让其可见被可追溯？

GMP 指南 1.12

  • 所有涉及外包的情况均是帮助/建议方式而不是直接执行？

  • 是否维护了本公司知识渊博员工所有权的正确平衡？

  • 是否有协议？如果将QRM 要素由外包公司执行，公司是否对受托方的能力进行了充分评估？

2.11

-Are risk assessments performed sufficiently early to allow appropriate risk mitigation where the risk assessments are being used proactively?

GMP Guide 1.12

-风险评估执行是否足够早，以在主动使用风险评估的情况下适当缓解风险？

GMP Guide 1.12

2.12

-Supports continual improvement?

ICH Q10

-支持持续改进？

ICH Q10

2.13

  • Are risks reduced to an acceptable level?

  • Do the conclusions from the risk assessment reflect the level of risk to the patient?

GMP Guide 1.13

  • 风险是否降低至可接受水平？

  • 风险评估的结论是否反映出患者风险水平？

GMP Guide 1.13

2.14

-Is the level of effort, formality and documentation of the quality risk management process identified and commensurate with the level of risk?

GMP Guide 1.13

-是否识别了质量风险管理过程的工作力度、正式程度和文件记录并与风险水平相称？

GMP Guide 1.13

3. Specific areas and activities where implementation of QRM might be expected

期望 QRM 实施的特定领域和活动

The following section provides guidance as to those activities where it would be reasonable to expect to find QRM principles being used in a manner that identifies, prioritises and mitigates risk. GMP Annex 20: (Potential Applications for Quality Risk Management) provides suggestions for implementation. This portion of the Aide-Memoire is intended to guide the inspector

以下部分是合理预期看到 QRM 原则应用于识别、优先排序和缓解风险的活动。GMP 附录 20

（QRM 潜在应用）为实施提出了建议。本备忘的本部分意在给检查员提供指导。

  • to those areas where there should be evidence as to extent that QRM has been implemented. Depending upon the maturity of implementation, QRM may be found to be totally absent, partially, superficially, incorrectly applied or fully implemented.

  • 应有证据证明 QRM 实施程度的领域。根据实施成熟度，可发现 QRM 总体缺失、部分缺失、极度缺失、不正确使用或全面实施。

  • to the extent that the scope of risk management/ assessments are appropriate and not being used to override GMP and other regulatory requirements.

  • 风险管理/评估范围恰当程度，未被用于推翻 GMP 及其它法规要求。

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Crucial indicators and related questions

关键指标和相关问题

Reference

引用

3.1

To what extent does the company use the potential applications of QRM suggested in ICH Q9?

GMP Guide Annex 20

公司使用 ICH Q9 中建议的 QRM 潜在应用到何种程度？

GMP 指南附录 20

3.2

Are references included in the controlling procedures or can the company explain how the QRM principles are integrated in the Quality System?

GMP Guide 1 Principle

控制程序中是否包括有引用内容，或公司是否可解释QRM 原则是如何结合到质量体系的？

GMP 指南原则

3.3

The following areas of operation are examples of where there should be evidence of the implementation of QRM principles:

以下操作领域是应该找到 QRM 原则实施证据的例子

3.4

-Deviations, OOS-Results, Investigations and CAPA

GMP Guide: 1 Principle & ICH Q10

-偏差，OOS 结果，调查和 CAPA

GMP 指南 1 原则&ICH Q10

3.5

-Complaints and recalls

GMP Guide 1Principle

-投诉和召回

GMP 指南 1 原则

3.6

  • Change control

    • Introduction of new manufacturing products or processes

    • Method and product transfer

    • Facility and equipment changes

GMP Guide 1Principle

  • 变更控制

    • 引入新的产品或生产工艺

    • 方法和产品转移

    • 设施和设备变更

GMP 指南 1 原则

3.7

-Method of sampling and testing

-取样方法和检测方法

3.8

-Supplier qualification and raw material supply chain robustness and supply chain traceability

GMP Guide 1Principle

-供应商确认和原料供应链稳健性和供应链可追溯性

GMP 指南 1 原则

3.9

-Validation and qualification

GMP Guide Annex 15

-验证和确认

GMP 指南附录 15

3.10

-Outsourcing and supply chain robustness

GMP Guide: Principle & ICH Q10

-外包和供应链稳健度

GMP 指南原则&ICH Q10

3.11

-Reworking and reprocessing

GMP Guide Principle

-再加工和返工

GMP 指南原则

3.12

-In process monitoring

GMP Guide Principle

-中控监测

GMP 指南原则

3.13

-Calibration and maintenance

GMP Guide Principle

-校正和维保

GMP 指南原则

3.14

-Storage and distribution conditions

GMP Guide Principle

-存贮和分发条件

GMP 指南原则

3.15

-Auditing program

GMP Guide Principle

-审计计划

GMP 指南原则

3.16

-Periodic review of products, processes and procedures

GMP Guide: 1.10 & Principle

-定期审核产品、工艺和程序

GMP 指南：1.10&原则

3.17

Is there any evidence of QRM being used inappropriately such as:

  • To justify failure to meet regulatory requirements and commitments.

  • To release batches to market that fall into the category

above or to justify increased risk to patient safety from batch deviations.

是否有证据证明 QRM 被不当使用，如

  • 证明不符合法规要求和承诺

  • 将属于上述类别的批次放行销售，或证明批次偏差增加了患者安全风险

4. Review of residual risk 残留风险的审核

Following implementation a company should be performing, communicating and documenting periodic reviews of the currency of its risk assessments and outcomes of its risk management plans. This section of the Aide-Memoire looks for evidence that there is a mechanism for routine and triggered review of risk assessments and their associated management plans in the case of significant change or new information coming to light.

在实施之后，公司应该对其风险评估的现行情况及风险管理计划的结果执行定期审核，并进行沟通和记录。本备忘的本部分是寻找证据证明有日常审核，和在有重大变更或发现新信息时激活风险评估及相关管    理计划审核的机制。

A model for Management Review is provided in ICH Q10. A risk register or equivalent is useful to facilitate review by both the company and the inspector.

管理审评的模型在 ICH Q10 中有提供。风险登记或等同方法可用于帮助公司和检查员进行审核。

Nr.

编号

Crucial indicators and related questions

关键指标和相关问题

Reference

引用

4.1

Is there a robust system to ensure that all the risk reduction measures (by mitigation or avoidance) have really been implemented in the manner they appear in the risk assessment?

是否有稳健的系统确保真正按风险评估中出现的方式实施了所有风险降低措施（通过缓解或回避）

4.2

Are individual risk assessments and their outcomes reviewed, controlled and re-assessed periodically for currency?

Are they still relevant to ongoing circumstances and controls?

Is there a mechanism to trigger a review of risk assessments and management plans in the case of significant change or new information from e.g. complaints, investigations, change control etc.?

ICH Q10

单个风险评估及其结果是否经过审核、控制并定期重新对其是否现  行适用进行重新评估？

它们是否与持续环境和控制相关？

如果有来自投诉、调查、变更控制等的重大变更或新信息，是否有  机制激发对风险评估和管理计划的审核？

ICH Q10

4.3

Are the reviews of the risk management plans effective; for example are the following covered:

风险管理计划的审核是否有效，例如是否包括以下：

4.4

Frequency

GMP Guide 1.12

频次

GMP 指南 1.12

4.5

-Responsibilities

GMP Guide 1.12

-职责

GMP 指南 1.12

4.6

-Formality of documentation appropriate to the level of review

GMP Guide: 1.12 & 1.13

-文件记录的正式程度适合于审核的水平

GMP 指南 1.12&1.13

4.7

-Visibility and communications of outcomes

GMP Guide 1.12

-结果的可视度和沟通

GMP 指南 1.12

4.8

-Recommendations and follow up

GMP Guide 1.13

-建议和跟踪

GMP 指南 1.13

5. Review and improvement of QRM activities

QRM 活动的审核和改进

Following implementation a company should be performing, communicating and documenting periodic reviews of the extent to which the QRM system is fully integrated into its activities, and managed and implemented effectively, and to promote continual improvement of the system.

实施后，公司应就 QRM 系统完全整合到其活动中的程度，有效管理和实施的范围进行定期审核、沟通和记录，并促进系统的持续改进。

A model for Management Review is provided in ICH Q10.

管理审评的模型在 ICH Q10 中已提供。

Nr.

编号

Crucial indicators and related questions

关键指标和相关问题

Reference

引用

5.1

Are the QRM processes subject to periodic and triggered review?

QRM 流程是否会被定期审核和被激活审核？

5.2

Are the reviews of the QRM system effective; for example are the following covered:

QRM 系统的审核是否有效，例如是否包括以下：

5.3

-Frequency

GMP Guide 1.12

-频次

GMP 指南 1.12

5.4

-Responsibilities defined

GMP Guide 1.12

-规定的职责

GMP 指南 1.12

5.5

-Formality of documentation appropriate to the level of review

GMP Guide: 1.12 & 1.13

-文件记录的正式程度适合于审核的水平

GMP 指南 1.12&1.13

5.6

-Visibility and communications of outcomes

GMP Guide 1.12

-结果的可视度和沟通

GMP 指南 1.12

5.7

-Recommendations and follow up

GMP Guide 1.12

-建议和跟踪

GMP 指南 1.12

Revision history 修订历史

Date

日期

Version Number

版本号

Reasons for revision

修订原因

1 January 2021

PI 038-2

Minor edits to update cross-references to PIC/S GMP Guide (PE 009-14)

20200101

PI 038-2

编辑修订，更新对 PIC/S GMP 指南（PE 009-4） 的交叉引用
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