“Changing the Concept of Quality” – Quality and Regulatory Guru Tom Beil Talks With Man Chem’s Hilary Ayshford


“The cost of a pharmaceutical ingredient is determined by far more than its monetary value,” writes Hilary Ayshford, Editor of Manufacturing, in the introduction to her interview with Tom Beil, VP of Quality and Regulatory Affairs at Sigma-Aldrich.

Tom Beil, VP, Quality and Regulatory Affairs, Sigma-Aldrich

Never a truer word has been spoken, or written in this case and, despite a decrease in both the number of recorded cases of suspected IP infringement AND the number of good detained under such suspicion in 2009 (compared to 2008) by EU customs, the numbers are still a major cause for concern to the global pharma and bio-pharma industries.

In the article ‘Changing The Concept of Quality,’ published in the current issues of Manufacturing Chemist, Beil talks about the ongoing problem of counterfeit pharma and how the perception of quality is changing as “more people start to look at their supply chain, the more they realize that they don’t know where those products come from.”  As a result, the total cost of quality is now something more than a buzzword…. Moreover, it’s looking at the overall supply chain as a matrix rather than a linear process.

The importance of quality and the auditing system required globally to ensure that the pharma industry is doing its utmost to prevent both supply chain failures and the threat of counterfeit, that SAFC, along with numerous other pharma players, became founding partners in Rx-360, “a consortium that is aimed at assuring the quality and authenticity of the products moving through the supply chain. Members also include Abbott, Amgen, BASF, Boehringer Ingelheim, AstraZeneca, GSK, Novartis and Pfizer, as well as many other notable names.”

You can read Hilary Ayshford’s fine article in full right here.

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