ISPE issues a white paper on supply chain security

Pharmaceutical CommercePharmaceutical Commerce - September/October 2010

Advisory panel recommends “signal monitoring” to anticipate potential risks

Although it lacks a supply-chain focused work group, the International Soc. For Pharmaceutical Engineering (ISPE; Tampa, FL) has published a white paper on supply chain security for both ingredients and finished products. The report is available, free, at ISPE’s website,

ISPE used what it calls its International Leadership Forum to author the report, Supply Chain Security: A Comprehensive and Practical Approach.” For the most part, the paper provides sensible, simple procedures to evaluate and audit the performance of materials suppliers, logistics providers and manufacturers’ own internal practices. Some parts are fairly tedious (recommending, for example, that quality inspectors check both the left and the right sides of shipping containers), but also present some valuable new thinking. One example of that is a recommendation to monitor supply disruptions such as plant shutdowns or unseasonable weather—situations that could lead to material shortages and price hikes—as opportunities for bad actors to begin marketing adulterated or fake products.

The report skips over the existence of pedigree programs—important, in some states, as a means of product authentication. Among the “opportunities for deterrence” it mentions is use of security features (overt, covert, forensic, tamper-evidence, and serialization/track and trace). It also recommends carefully evaluating the practices of the “customer,” defined as the first point where legal ownership of product changes—but says next to nothing about second- or third transaction points. It also highlights the need for theft prevention in storage facilities or cargo transport.

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