There will be technical and scientific issues as well. For instance, while investigating the heparin recall, FDA found that
the heparin API supplied by SPL to Baxter contained a heparin-like compound that was not heparin but reacted like heparin
in traditional analytical tests. FDA did not immediately establish a causal link between the contaminant and the adverse events
but issued guidelines for additional analytical tests to identify the foreign substance.
In fact, comprehensive analytical testing is likely to become a more important link in pharma's global supply chain and in
FDA's efforts to maintain the safety of human and animal products. This will become a major opportunity for contract analytical
labs, especially the worldwide laboratory networks run by companies such as SGS and Intertek, which already have extensive
consumer-testing operations and dozens of facilities around the world. Other contract analytical services providers have been
slow to establish operations in India and China but are likely to move more deliberately in the near future.
The explosive growth offshore sourcing by the pharmaceutical industry is a relatively recent phenomenon and is directly related
to margin pressures felt by pharmaceutical companies resulting from efforts by governments and health insurance providers
worldwide to slow the growth of healthcare expenditures. Offshore sourcing has grown so quickly that it has overwhelmed the
systems put in place by industry to maintain product quality and safety, and it has afforded no room for "on-the-job" learning.
Regulatory agencies and pharmaceutical companies will have to devote more resources to anticipating potential supply-chain
risks and implementing mechanisms to prevent them.
Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, fax 703.383.4905, email@example.com