Allan Coukell, director of the Medical Programs Pew Health Group at The Pew Charitable Trusts, provided a global perspective
on this issue. He pointed out that outsourcing has grown exponentially over the past 10 years, complicating the already complicated
pharmaceutical supply chain. In discussing this complexity, he brought to light some disturbing facts, including that FDA
483 observations to contract manufacturers have risen over the past three years. In addition, Coukell noted that "FDA has
expressed concerns about deficiencies in supplier qualification programs and quality agreements and that current regulations
do not require companies to assess supplier plants before purchasing ingredients from them, or to visit the plants at any
time to ensure quality standards are in place." He further highlighted the steps being taken to address this gap in regulations
through the passage of new laws such as the 2012 FDA Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendment
(GDUFA). He also complimented industry on some of its initiatives aimed at resolving supply-chain issues, including the efforts
of Rx-360 (the international pharmaceutical supply chain consortium), EXCiPACT (a voluntary international scheme to provide
independent third-party certification of manufacturers, suppliers, and distributors of pharmaceutical excipients worldwide),
and International Pharmaceutical Excipient Auditing (IPEA), which also provides third-party audits through a shared audit
program and ANSI accredited certification program.
It is important for industry to understand and work to improve their client–service provider relationships. Such re-evaluations
make both sponsors and CMOs more effective in achieving the goal of improving public health and safety.
Susan J. Schniepp is vice-president of Quality and Regulatory Affairs at Allergy Laboratories, Oklahoma City, OK 73109. Tel. 405.235.1451,