In considering the pharmaceutical supply chain and management of change, there are two particular areas in the processing cycle that can expose a company's products to risk. The first is at the start of the chain, when there is potential for contamination of raw materials—active or inactive. The second is at the end of the chain, when the finished product, sealed in its final container, is distributed. This article addresses both topics, their overall management, and individual product control strategies that a company might consider.

Counterfeit risks

Counterfeiting medicines presents a relatively safe way of generating money. Criminal organizations, with terrorists high on the list, are constantly seeking new ways to obtain funds. Sadly, the pharmaceutical marketplace has become a setting for them to do so. Active pharmaceutical ingredients (APIs) present an opportunity to infiltrate the system early in the supply chain, generating high income. With a little analytical knowledge and understanding of the types of incoming tests performed on materials at finished dosage form manufacturers, counterfeiters are finding sophisticated ways of introducing their fakes into the genuine supply.

Recent estimates from the World Health Organization (WHO) place the pharmaceutical counterfeiting trade as high as 10% of overall commerce in medicinal products. The horrendous growth rate of this bogus industry is set to overtake that of genuine pharmaceuticals by 2010. In 2006, WHO set up a global task force known by the acronym IMPACT, which stands for International Medical Products AntiCounterfeiting Taskforce. The taskforce suggested that key areas of activity tied to combatting counterfeiters include legislation, regulations, enforcement, technology, and communication strategies. However, WHO has stated that the primary driver for anticounterfeit measures should be regulatory agencies and enforcement activities. The US Congress has adopted a similar approach, mostly recriminatory, toward the US Food and Drug Administration subsequent to the heparin recall earlier this year. However, regulators and their regulations, while essential in reducing it, will never be able to entirely prevent criminal activity.

The primary intent of good manufacturing practice (GMP) and good distribution practice (GDP) regulations is to provide minimum standards for those manufacturers and distributors interested in setting up effective quality systems and to minimize the likelihood of substandard products caused by negligence or lack of knowledge. Where there is intent to defraud, it is industry that needs to proactively design preventive measures into its supply chain through company policies and procedures and effective training of concerned personnel. The self-interest of genuine pharmaceutical manufacturers to seal off potential penetration points for counterfeit product suggests that the ICH (International Conference on Harmonization) approach, in which legislators and industry representatives work closely to develop guidance, might result in the implementation of rapid and effective measures against those who have the potential to harm industry. Indeed, US regulators have already reached out to industry and set up at least one such task force, resulting in the Sept. 2008 PDA/FDA Supply Chain Conference held in Washington, DC.

It is therefore appropriate that anticounterfeiting measures for the distribution chain be designed into a product as part of a company's control strategy. These measures can include electronic tagging, tamper-evident seals, holograms, and so forth, as a standard for both finished product and active substances as well as industry investment (possibly in conjunction with the electronics and security industries) in development of novel measures.

The 2008 heparin recall resulted from contamination of the raw material with large amounts of chondroitin, which is difficult to detect, especially if a company is performing reduced testing (identity only) on most incoming batches. Whether the contamination was deliberate has not yet been firmly established, although there are indicators that it might have been. FDA has not come out of the episode smelling of roses–owing to a "computer glitch" that they inspected the wrong site. In its defense, FDA claims an unmanageable situation whereby the agency is expected to regulate a supply chain spreading across five continents with resources that barely suffice for the US alone. Where does this leave industry?