The Drug Industry Plays Catch Up
In a recent issue of Pharmaceutical Manufacturing Magazine, John Walker, a Program Director at Business Enterprise Mapping Inc., was interviewed regarding the imminent emergence of the ICH Q-10 standard for Quality Management Systems (QMS) in the pharmaceutical industry.
In the interview Walker emphasized that several other heavily regulated industries have already successfully made the transition to an ISO 9000-based QMS and that all approaches to implementation are not equally efficient and effective. Properly implemented, the transition is enormously beneficial to the enterprise and fully consistent with best business practices. Conversely, if approached solely as an onerous compliance imperative, the whole exercise can be an expensive, non-value-added chore. Caveat Emptor!
Business Enterprise Mapping’s approach is unanimously considered best-in-class by those accredited third-party auditors that have encountered it.
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Tags: cGMPs, enterprise mapping, ICH Q-10, ISO 9001:2000, pharma, Pharmaceutical Quality System
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