Global clarification and escalation of pharmaceutical regulations has resulted in increasingly complex audits. Audits today are more frequent, longer in duration, and deeper in scope, which results in amplified challenges for effective audit management. The outcome of the audit is often influenced by the firm’s ability to effectively manage the audit. An audit with a poor outcome can have major affects on a company.
Ben Venue Laboratories (BVL) is a prime example of what can happen when quality assurance is overlooked. In December 2011, the BVL plant in Ohio was shut down after a joint inspection from US, UK, and France. This resulted in a recall of their drugs, Caelyx and methotrexate, both used in cancer treatments. By February 2012, with the BVL plant idled, the U.S. predicted extreme shortages of these drugs within two weeks.1 The FDA was forced to make a temporary agreement with India’s Sun Phama for the short-term use of their product, Lipodox, a similar drug that is not yet legal in the U.S. 2 This inspection alone caused the shutdown of a plant, scarcity of cancer treatment drugs, and risk from permitting the use of drugs not yet approved in the U.S. When inspections cause an epidemic like this, it can have monumental effects on the company.
“I think some customers moved out … and found other sources, while others stuck with BVL perhaps thinking the problems would get resolved… We’re certainly seeing a level of activity from those customers, and their starting point is, ‘Give us some comfort on your regulatory position.’”
- Stuart Hinchen, JHP Pharmaceuticals , 4/2012 Contract Pharm “Parental Outsourcing Trends”
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- Tracy Staton. February 2012. FiercePharma. “Ben Venue’s idled plant triggers ‘dire’ leukemia-drug shortage”
- Tracy Staton. February 2012. FiercePharma. “FDA brings Sun’s Doxil copy online to fix shortage”.