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:
Culminating in 2006 there were a number of global events which created a shortage of dairy products. This shortage caused an increase in the price of dairy product, signaling a potential for suppliers to substitute a less expensive material for the expected product. Inexpensive materials such as melamine were used to inflate the protein content of foods when tested with traditional analytical methodology. The adulteration was first detected in cat and dog food resulting in pet food recalls in the US in 2007 in response to reports of kidney failure in pets. Similarly, reports of melamine adulteration of baby food surfaced in late 2008 with reports of kidney stones in children in China.
In addition to this example about dairy products, the report describes how shortages of acetronitrile (an organic solvent) and glycerin contamination resulted in widespread international complications.
For more information about how pharma companies can facilitate security and mitigate risks in their supply chain, see the 28-page report available here.