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Executive Briefing Series (formerly The Food & Drug Letter)
April 6, 2012
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Supplier qualification has emerged as a hot-button issue for FDA inspectors. A 2011 warning letter to ReBuilder Medical, a maker of nerve stimulators, highlights the level of detail that inspectors are examining during inspection. The seven-citation letter notes defects in the signal generator components supplied to the devicemaker, inadequate records of ReBuilder’s efforts to correct the defect and a lack of documentation for contacting the supplier to discuss the potential cause. While ReBuilder is a devicemaker, the FDA has said it plans to increase oversight of drug suppliers as well. For example, to ensure the quality and consistency of final drug products, the FDA is considering a requirement that drugmakers audit their raw material suppliers for compliance with good manufacturing practices. The agency is also considering issuing warning letters to end-product manufacturers when their suppliers fail an FDA site inspection. This issue of The Food & Drug Letter looks at the FDA’s current thinking on supplier audits and what companies need to know in order to conduct a successful audit program, determine the scheduling and frequency of audits and select a qualified auditor to do the job.
The FDA is working on a revision to good manufacturing practice (GMP) regulations that would require pharmaceutical companies to audit raw material suppliers, a former FDA official says.
The quality of any material that goes into a medicinal product remains the manufacturer’s responsibility.
When manufacturers work with multiple suppliers, they obviously must audit each supplier.
Reduced testing represents the ultimate goal of any company in establishing relationships with many of its suppliers.
Auditing suppliers is an expensive undertaking that requires a serious commitment of time and resources.
Supplier auditors require appropriate training and experience to perform a successful appraisal.
The FDA may begin issuing warning letters to drugmakers when their contracted suppliers fall out of agency compliance, signaling further agency efforts to strengthen the safety of pharmaceutical supply chains.
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