Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap.

Knowledge management (KM) is identified in ICH Q10 (Pharmaceutical Quality System), as a key enabler to the pharmaceutical quality system (PQS). ICH Q8 (Pharmaceutical Development), ICH Q11 (Development and Manufacture of Drug Substances), and ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) 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 enabler in ICH Q10 to a key consideration (both technical and regulatory) in ICH Q12.

Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.

This article is the first in a series of articles that will focus on understanding the implementation essentials necessary to deliver operational excellence through a International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q10-based pharmaceutical quality system (PQS). The authors examine why, despite the fact that the ICH Q10 guideline has been with us since 2008, the transformation of the traditional Quality Management Systems QMS in use within the pharmaceutical industry is a work in progress for only a few forward-thinking organisations. Unfortunately, this transformation remains a mere aspiration for the majority of organisations. We explore the apparent lack of progress by the pharmaceutical sector in adopting six sigma and related quality management techniques to ensure the availability of high-quality medicines worldwide. The authors propose that the desired progress can be delivered through two key shifts in our current practices; by embodying the principles of operational excellence in every aspect of our business and by learning how to unlock the scientific and tacit knowledge within our organisations. LAY ABSTRACT: It has been ten years since The Wall Street Journal revealed the pharmaceutical industry's "little secret" comparing the perceived level of manufacturing expertise in the industry as lagging far behind those of potato-chip and laundry-soap makers. Would you consider the quality and manufacturing strategies in place today in your organisation to be more efficient and scientifically based than those of 2003? If so, what evidence exists for you to draw any conclusion regarding enhanced performance? Do your current practices drive innovation and facilitate continual improvement and if so, how? Ultimately, can you confidently affirm that patient-related risks associated with the product(s) manufactured by your organisation have been reduced due to the quality assurance program now applied within your organisation? This article asks you to question if you have truly embraced Q8(R2), Q9, and Q10, and in doing so can you demonstrate that you have made the necessary changes that would warrant reduced regulatory oversight?

Quality Risk Management: Putting GMP Controls First.

This paper presents a practical way in which current approaches to quality risk management (QRM) may be improved, such that they better support qualification, validation programs, and change control proposals at manufacturing sites. The paper is focused on the treatment of good manufacturing practice (GMP) controls during QRM exercises. It specifically addresses why it is important to evaluate and classify such controls in terms of how they affect the severity, probability of occurrence, and detection ratings that may be assigned to potential failure modes or negative events. It also presents a QRM process that is designed to directly link the outputs of risk assessments and risk control activities with qualification and validation protocols in the GMP environment. LAY ABSTRACT: This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered to be any control that is put in place to assure product quality and regulatory compliance. This improved approach is also based on how the detectability of risks is assessed. This is important because when producing medicines, it is not always good practice to place a high reliance upon detection-type controls in the absence of an adequate level of assurance in the manufacturing process that leads to the finished medicine.