@Risk

Supply chain security is now a top concern for companies throughout the pharmaceutical industry. Several recent high profile cases have underscored vulnerabilities, and most pharma organizations now recognize that a holistic approach is required to detect and prevent adulteration, counterfeiting, illegal diversion, and theft.

Last month, ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, released a white paper to help firms address these critical supply chain issues. “Supply Chain Security: A Comprehensive and Practical Approach” encourages pharmaceutical companies to strengthen their overall supply chain security by adopting a layered approach that includes:

• Signal detection and response

• Supplier quality management

• Management of logistics and transportation services providers

• Additional specific programs

I found the discussion of signal detection and response particularly interesting, as it illustrates how adulteration of one particular excipient can have broad effects on the quality of finished products across several countries and can impact several organizations. Here’s an example from the report: (more…)

The US Food and Drug Administration has released new recommendations designed to help pharmaceutical manufacturers better control the use of at-risk components that may be contaminated with melamine.

The 8-page industry guidance document, Pharmaceutical Components at Risk for Melamine Contamination, includes a list of potential at-risk compounds —several of which are rather commonplace (gelatin, guar gum, lactose, e.g.).

The FDA also outlines these specific recommendations:
(more…)