Lipa Martin J, Greene Anne, Calnan Nuala
Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486; and
School of Chemical and Pharmaceutical Sciences, TU Dublin-City Campus, Kevin Street, Dublin 8, Ireland.
PDA J Pharm Sci Technol. 2021 Jan-Feb;75(1):64-90. doi: 10.5731/pdajpst.2020.011825. Epub 2020 Jul 16.
Knowledge management (KM) is identified in ICH Q10 (), as a key enabler to the pharmaceutical quality system (PQS). ICH Q8 (), ICH Q11 (), and ICH Q12 () each build on the expectation that knowledge will be managed effectively in order to support and improve the product and process across the pharmaceutical product life cycle. However, in spite of the fact that KM was introduced in ICH Q10 over 10 years ago, there is ample evidence that it is not yet a mature discipline within the biopharmaceutical sector, and the authors suggest that this could hinder full realization of the potential benefits of ICH Q8, ICH Q11, and ICH Q12. The Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Technological University (TU Dublin) in Ireland, has been conducting research on KM for several years, and this paper presents the next phase in this research. Specifically, the focus of this current research was to explore ways to offer practical solutions to improve the management of knowledge across the pharmaceutical product life cycle, starting with a focus on enhancing knowledge transfer during technology transfer projects. The typical challenges associated with ineffective knowledge transfer were presented and the high-level requirements needed to address these were identified through the research. From these requirements, a four-step framework was developed as a systematic means to enhance knowledge transfer. Accompanying the framework was a KM toolkit consisting of a range of KM practices (tools, processes, and behaviors) to facilitate more effective knowledge flow during technology transfer. It was then illustrated how such a framework can be extended across the entire pharmaceutical product life cycle, supporting the advancement of KM from an in ICH Q10 to a (both technical and regulatory) in ICH Q12.
知识管理（KM）在国际人用药品注册技术协调会（ICH）Q10中被确定为药品质量体系（PQS）的关键推动因素。ICH Q8、ICH Q11和ICH Q12均基于这样的预期构建，即知识将得到有效管理，以支持和改进整个药品生命周期中的产品和工艺。然而，尽管ICH Q10在10多年前就引入了知识管理，但有充分证据表明，它在生物制药领域尚未成为一门成熟的学科，作者认为这可能会阻碍充分实现ICH Q8、ICH Q11和ICH Q12的潜在益处。爱尔兰都柏林理工大学（TU Dublin）的制药监管科学团队（PRST）多年来一直在进行知识管理研究，本文介绍了该研究的下一阶段。具体而言，当前这项研究的重点是探索提供实际解决方案的方法，以改进整个药品生命周期中的知识管理，首先关注加强技术转移项目中的知识转移。文中介绍了与无效知识转移相关的典型挑战，并通过研究确定了解决这些挑战所需的高层次要求。基于这些要求，开发了一个四步框架，作为加强知识转移的系统方法。与该框架配套的是一个知识管理工具包，其中包括一系列知识管理实践（工具、流程和行为），以促进技术转移过程中更有效的知识流动。随后说明了这样一个框架如何能够扩展到整个药品生命周期，支持知识管理从ICH Q10中的一种理念发展到ICH Q12中的一种能力（包括技术和监管能力）。
