【中文翻译02】ISPE 良好实践指南:制药行业的知识管理

2023-12-04 51

【英文】ISPE Good Practice Guide: Knowledge Management in Pharmaceutical Industry;【中文】ISPE 良好实践指南:制药行业的知识管理;发布时间:2021年5月;指南页数:160页;指南章节数:23章

中文翻译02:1. 引言(1.1 - 1.6)

1 Introduction

1 引言


The development and manufacture of biopharmaceutical products is a highly complex scientific endeavor, and individuals and organizations have always managed knowledge in various ways and to varying degrees of effectiveness. Anecdotally, there are arguably familiar challenges associated with managing knowledge such as:

  • Poor filing systems
  • Multiple competing databases
  • Different Information Technology (IT) systems across different departments and across the product lifecycle
  • Challenges in finding Subject Matter Experts (SMEs)
  • Difficulty in understanding why certain decisions were made
  • Repeated issues and mistakes (not learning lessons)
  • Difficulty in finding historical product knowledge
  • Incomplete knowledge transfer
  • 糟糕的文档系统
  • 多个互不兼容的数据库
  • 产品全生命周期中跨部门的不同 IT 系统
  • 寻找 SME 的挑战
  • 难以理解做出某些决定的依据
  • 重复的问题和错误(不能吸取经验教训)
  • 难以追溯历史产品知识
  • 知识转移(传播)不完整

Further, the wide availability of personal computerized systems and various electronic databases has made findability of knowledge increasingly complex. As the pace of data accumulation and the associated knowledge generation continues to accelerate, the need to manage knowledge systematically has become increasingly apparent, important, and expected.


1.1 Background

1.1 背景


In the pharmaceutical industry, consistency of product quality (composition and performance) within and between lots is critically important for the patient as the ultimate user, and by extension, for all those engaged in its provision. There is now a global general acceptance that the control of product quality must commence during product development and continue up to, and in certain respects beyond, the time of product discontinuation from the market. The Quality Guideline Series from ICH [1] describe foundational principles for the achievement of process understanding and quality throughout the product lifecycle. This is based on the belief that quality cannot be tested into products but rather should be built in by design and demonstrated by the results and conclusions of the development studies undertaken. With new countries joining ICH, the guidelines are approaching a de facto standard, although there remain differences in levels of adoption and regional interpretations.

在制药行业,产品批次内和批次间的质量(成分与效用)一致性,对于作为终端用户的患者,以及所有参与其生产供应的人员来说,都至关重要。现在全球普遍认为,产品质量控制必须从产品开发期间就开始,并持续到产品停产退市(在某些方面甚至要超过产品停产退市的时间)。ICH [1] 的质量指南系列描述了在整个产品生命周期中实施过程工艺和质量管理的基本原则。这是基于这样一种信念:质量不能通过产品测试来保障,而应源于设计,并通过开发研究的结果和结论来证明。随着新的国家加入 ICH,该指南正在接近事实上的标准,尽管在不同地区的实施采纳程度解释方面仍存在些许差异。

Within the ICH Quality Guideline Series, the topic of applying prior knowledge, and more broadly Knowledge Management (KM), emerged starting with ICH Q8 [2] Pharmaceutical Development. This has been reinforced in subsequent guidelines. Recommended for adoption in November 2005, ICH Q8 introduced a number of new key concepts including Quality by Design (QbD), Design Space, Quality Target Product Profile (QTPP), and Critical Quality Attributes (CQAs). These concepts are discussed in greater detail in Section 10.1.1.

在 ICH 质量指南系列中,如何应用先验知识这个话题,以及更广泛的知识管理 (KM) 相关主题,从 ICH Q8 [2] 药物开发 就开始出现了。这一点在随后的指南中被更多提及和强调。ICH Q8 于 2005 年 11 月被推荐采用,引入了许多新的关键概念,包括质量源于设计 (QbD)、设计空间、质量目标产品概况 (QTPP) 和关键质量属性 (CQAs)。这些概念在第 10.1.1 节中有更详细的讨论。

It is, however, noteworthy that ICH Q8 [2] provides the first reference to the concept of KM in the field of pharmaceutical quality. In ICH Q8, KM is a tool to be used along with Quality Risk Management (QRM) for a more systematic QbD approach to development throughout the lifecycle of the product.

值得注意的是,ICH Q8 [2] 首次在药品质量领域引用了知识管理的概念。在 ICH Q8 中,KM 是一种与质量风险管理 (QRM) 一起使用的工具,为药品全生命周期中提供更系统的 QbD 开发方法。

ICH Q9 [3] (also recommended for adoption in November 2005) describes in detail the principles and practices of QRM. While ICH Q9 makes no explicit reference to KM, it makes multiple references to the knowledge available for making risk-based decisions, for example:

ICH Q9 [3](也于 2005 年 11 月被推荐采用)详细描述了 QRM 的原理和实践。虽然 ICH Q9 没有明确提及知识管理,但它多次提及如何利用已有知识帮助制定基于风险的决策,例如:

“The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient.”


Following ICH Q9, ICH Q10 [4] was adopted in 2008 and specifically identified KM as one of the two enablers of a PQS, stating:

继 ICH Q9 之后,ICH Q10 [4] 于 2008 年被采用,其中明确将知识管理定义为 PQS 的两大推动力之一,指出:

“Use of knowledge management [italics in original] and quality risk management will enable a company to implement ICH Q10 effectively and successfully.”

“使用知识管理[原文斜体]和质量风险管理将推动企业能够有效、成功地实施 ICH Q10。”

Furthermore, ICH Q10 [4] connects the successful implementation of an effective PQS, enabled by KM and QRM, to the interest of public health and establishes the connection to innovation and continual improvement as follows:

此外,ICH Q10 [4] 将 KM 和 QRM 促成的有效 PQS 成功实施与公共卫生利益联系起来,并建立了与创新和持续改进的联系,如下所示:

“ICH Q10 demonstrates industry and regulatory authorities’ support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.”

“ICH Q10 表明行业和监管机构对建立有效的药品质量体系的支持,以提高全球药品质量,维护公众健康。在药品全生命周期中实施 ICH Q10 应促进创新和持续改进,并加强药品开发和生产活动之间的联系。”

The realization of this desired state has been central to ISPE’s efforts to advancing the state of pharmaceutical quality within the industry [5], and this Guide supports those efforts by demonstrating the value of systematically managing organizational knowledge as part of that journey.

实现这种理想状态,对于 ISPE 努力提高行业内药品质量水平至关重要 [5],本指南也将通过阐述组织如何系统性地做好知识管理,贡献一份力量,任重道远。

The incorporation of KM in pharmaceutical organizations has been slower than in other industries [6, 7]. Beyond the specific arena of pharmaceutical quality, KM is becoming more widely recognized as a stand-alone discipline that focuses on ways organizations create, manage, and use knowledge. This is not surprising in the current era where business activities are becoming increasingly dominated by knowledge workers and the widespread utilization of complex digital systems for storing the ever-growing knowledge generated in different types of enterprises. ISO 30401 Knowledge management systems — Requirements [8] was published in 2018 with the stated objective to:

与其他行业相比,制药企业在知识管理方面的整合速度较慢[6, 7]。
在当今时代,商业活动越来越被知识工作者所主导,复杂的数字系统也被广泛使用,来存储不同类型企业产生的源源不断增长的知识。ISO 30401 知识管理系统 - 要求 [8] 于 2018 年发布,其既定目标是:

“...support organizations to develop a management system that effectively promotes and enables value-creation through knowledge.”


Thus, KM can be considered as an important enabler of an effective modern management system and the content of ISO 30401 is worthy of consideration. Appendix 15 provides further comparison between this Guide and ISO 30401, including a map of the contents of each document.

因此,知识管理可以被视为有效的现代管理体系的重要推动力,ISO 30401的内容值得参考。附录 15 中提供了本指南与 ISO 30401 之间的进一步比较,包括了每个文档内容的映射关系。

1.2 Purpose

1.2 目标


This Guide seeks to embrace and advance KM for the pharmaceutical industry.


The practical principles and methods and tools provided in this Guide are intended to help organizations improve their capabilities in managing knowledge and using that knowledge to support an effective PQS resulting in improved organizational performance, among other benefits. One such practical approach is the Knowledge Management Maturity Assessment Tool (see Appendix 3), which can be used to measure an organization’s KM maturity and identify opportunities for improvement.

本指南中提供的实用原则、方法和工具旨在帮助企业提高其知识管理的能力,并利用这些知识来支持有效的 PQS,从而提高组织效率以及收获其他好处。其中一种实用的方法是知识管理成熟度评估工具(参见附录 3),它可用于衡量组织知识管理的成熟度并识别改进机会。

The goals of this Guide are to:

  • Define and explore the meaning and importance of KM in the context of the pharmaceutical industry
  • Discuss the importance of KM to the PQS
  • Describe KM principles, key concepts, the general KM process, and foundational KM methods and tools
  • Discuss forward looking opportunities for KM
  • Share practical pharmaceutical applications and case studies of KM
  • 定义并探索知识管理在制药行业中的意义和重要性
  • 讨论知识管理对 PQS 的重要性
  • 阐述知识管理原则、关键概念、一般知识管理流程、基础的知识管理方法与工具
  • 讨论知识管理的前瞻性机会
  • 分享知识管理的实际制药行业应用和案例研究

This Guide is relevant to organizations across the pharmaceutical industry in their pursuit for effective and practical solutions to common KM issues.


1.3 Benefits

1.3 收益


It is envisioned that the practices presented in this Guide will result in broad benefits to a variety of stakeholders including patients, organizations involved in the discovery and manufacture of pharmaceutical products, regulatory agencies, and the employees of these organizations as knowledge workers. By further socializing and educating on the topic of KM, the understanding and resulting effectiveness of KM methods and tools can be meaningfully improved. The author team of this Guide in turn believes the pharmaceutical industry will be better positioned to realize the important objectives of ICH Q10 [4], ICH Q8 [2], and other regulatory guidances that prescribe the capture and application of knowledge.

我们预计本指南中介绍的方法,将为各类相关者带来广泛的利益,包括患者、参与发现和制造药品的组织、监管机构以及这些组织内作为知识工作者的成员。通过进一步对知识管理主题进行社会普及和教育,可以显著加强对知识管理方法和工具的理解,以及由此带来的效果。本指南的作者团队,相信制药行业将利用知识的获取和应用,更好地实现 ICH Q10 [4]、ICH Q8 [2] 以及其他监管指南。

1.4 Scope

1.4 范围


The scope of this Guide is aligned with the ICH Q10 [4] scope:

本指南的范围与 ICH Q10 [4] 范围一致:

“...systems supporting the development and manufacture of pharmaceutical drug substances (i.e., APIs) and drug products, including biotechnology and biological products, throughout the product lifecycle.”


The principles described may also be applied to medical devices, over-the-counter products, personal care, and cosmetics. In addition, to be maximally effective these principles should be applied throughout the product lifecycle from research and development, technology transfer, commercialization, up to and including product discontinuation.


1.5 Key Features

1.5 主要特征


This Guide provides a variety of materials to advance the understanding of KM and its application in pursuit of improved KM effectiveness and maturity to enable the aforementioned goals. This Guide features:

  • A description of the importance and associated benefits of effective KM
  • Definitions and principles behind KM and supporting concepts
  • Frameworks to enhance the understanding and application of KM
  • A section on Getting Started to foster the first steps for a KM effort
  • A maturity model to assess the current-state performance and identify opportunities to improve effectiveness
  • A variety of methods and tools, and systematic approaches to improve KM effectiveness
  • Advice to relate KM to other industry guidance
  • Case studies demonstrating the application of KM
  • 描述有效知识管理的重要性和相关益处
  • 知识管理背后的定义和原则以及支持概念
  • 加强知识管理理解和应用的框架 
  • 入门阶段,迈出知识管理工作的第一步
  • 评估当前状态效率,并确定提升空间的成熟度模型
  • 多种方法和工具,以及提高知识管理有效性的系统方法
  • 将知识管理与其他行业指南联系起来的建议
  • 知识管理相关的案例研究

1.6 Structure of the Guide

1.6 指南结构


This Guide is organized as follows:

  • Chapters 1 and 2 explain the Why behind KM
  • Chapters 3 and 4 provide basic information on KM to enhance the understanding of What KM is
  • Chapter 5 discusses KM Application across the product lifecycle
  • Chapter 6 introduces principles for digitally enabled KM
  • The appendices provide resources for the How and supplemental information
    • Appendices 1 – 7 discuss KM methods and tools
    • Appendices 8 – 13 present KM case studies
    • Appendix 14 contains example KM templates
    • Appendix 15 is a map of this Guide to ISO 30401 [8]
  • 第 1 章和第 2 章解释了 为什么 要知识管理
  • 第 3 章和第 4 章提供了基本信息,以增强理解 什么 是知识管理
  • 第 5 章讨论了知识管理在药品全生命周期中的应用
  • 第 6 章介绍了数字化知识管理的原则
  • 附录提供了大量资源补充说明 怎么样 实施知识管理附录 1 – 7 讨论知识管理方法和工具附录8 – 13 知识管理案例研究附录 14 包含知识管理模板示例附录 15 是本指南与 ISO 30401 的文档结构映射关系 [8]
  • 附录 1 – 7 讨论知识管理方法和工具
  • 附录8 – 13 知识管理案例研究
  • 附录 14 包含知识管理模板示例
  • 附录 15 是本指南与 ISO 30401 的文档结构映射关系 [8]