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European Biopharmaceutical Review

ICH Q9 and Beyond

 

Risk is often defined as a state of uncertainty where some of the possibilities involve a loss, catastrophe or other undesirable outcome. In supply chain terms, this means unexpected events can occur that cause the clinical supply chain to fail. The risk management process allows the degree of uncertainty to be reduced.

Modern regulations now focus on pharmaceutical quality systems and quality risk management processes. These are welcome initiatives and provide an excellent platform for the industry. They do not, however, go far enough, as they do not sufficiently recognise the need to address the end-to-end supply chain and the ‘systemic’ interdependencies that can present significant issues.

Figure 1 is a schematic of a supply chain to support a first-in-man study. Note that even an apparently ‘simple’ supply chain is a series of complex, interdependent linkages. Failure can occur at any point in a multitude of guises, often lurking in the most unexpected places. The further upstream the failure takes place, the more difficult it is to recover, emphasising the need for a comprehensive methodology of assessing and mitigating risk.


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Hedley Rees, Managing Director at Biotech PharmaFlow, graduated as an industrial engineer in 1975, spending his early career in light engineering and automotives. In 1979, he joined the UK manufacturing arm of Bayer AG, where he progressed through industrial engineering into planning and inventory control, purchasing and distribution, becoming site lead of supply chain management in 1990. He left the world of Big Pharma in the mid 1990s after completing an Executive MBA at Cranfield University School of Management. Since then, Hedley has been actively building, managing and continuously improving value chains in biotech, firstly in permanent roles with British Biotech, Vernalis and OSI Pharmaceuticals, and then running his own training and consultancy business, Biotech PharmaFlow. He is a corporate member of the Chartered Institute of Purchasing & Supply, sits on BIA’s Manufacturing Advisory Committee and writes articles and speaks in various biopharmaceutical publications and conferences.

Tim Williams is the Managing Director of I Balloon Ltd, an independent Project Management Training and Consultancy firm. Previously, Tim was the Business Director for Japanese Accounts at Autoliv Inc, based in their Asia Pacific Headquarters in Thailand. He was responsible for business case approvals, customer liaison activity, global and regional business opportunity and strategy management. From 2002 to 2006, Tim was based in Nagoya, Japan, where he managed and coordinated the global Camry passenger airbag development and manufacture. Tim has an Honours Degree in Mechanical and Manufacturing Engineering and in 2007 attained an MBA from the University of Manchester’s Business School. Email:

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