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.
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.
Counterfeit medicines are those that are deliberately contaminated or misbranded and constitute part of a wider group of substandard
pharmaceuticals. Substandard products are manufactured beneath minimum recognized standards of quality and thereby pose serious
hazards to the end-user. Unlike counterfeits, which are deliberately and fraudulently introduced into the supply chain, substandard
medicines are often the outcome of incompetence or negligence. In either case, pharmaceutical companies and regulators alike
have an interest in preventing these phenomena.
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?