spacer
home > ebr > autumn 2009 > ich q9 and beyond
PUBLICATIONS
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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

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:

spacer
Hedley Rees
spacer
spacer
spacer
Tim Williams
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Breakthrough in the global battle against polio: AJ Vaccines granted WHO prequalification for new polio vaccine

Despite ongoing concerted efforts to eradicate polio, it appears to be on the rise again with more cases registered in 2019 than 2018. Looking ahead, AJ Vaccines’ dose sparing technology provides a significant opportunity to expand supply, with the potential to deliver up to 100 million doses over the five-year period 2020-2024 to help meet the currently unmet global demand for inactivated polio vaccines.
More info >>

White Papers

Tabletability, Compactability, and Compressibilty: What’s the Difference?

Natoli Engineering Company, Inc.

To patients and consumers, tablets are a simple and convenient dosage form. But the science behind compressing a block of particles or granules into a single tablet can be complicated. That’s where common compression studies can help. This article explains how to develop tabletability, compactibility, and compressibility profiles.
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement