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Managing quality in global supply chain

QA challenges mount as pharmaceutical companies outsource manufacturingPharmaceutical supply chains have become complex beasts. As drug manufacturers use more and more international suppliers as CMOs (contract manufacturing organizations) and sub-contractors, consumers, physicians, and regulators are demanding adherence to robust QA processes throughout the global manufacturing of pharmaceuticals.

Nearly 80% [PDF link] of all drug substances are manufactured outside of the US. As we have seen with the contaminated heparin from China, there has been lax GMP oversight at many foreign facilities. Coupled with the fact that FDA struggles to inspect overseas facilities, it behooves industry to develop and maintain solid vendor relationships.

It is becoming clear that the pharma industry cannot delegate quality to CMOs. While Baxter's reputation has been adversely impacted by the heparin tragedy, few people know the name of the CMO where their heparin had been manufactured.

FDA is making concerted efforts towards better control of the pharmaceutical quality system through quality-by-design principles. The agency is relying on ICH Q10 [PDF link] as a model. The guidelines states that "responsibilities ... for quality-related activities ... should be included in a written agreement between the contract giver and contract acceptor."

As FDA cracks down on vague (or missing) quality agreements, it is likely that more warning letters will be issued to U.S.-based pharma companies. Poor quality agreements with CMOs don't pay!

Further information:
Marion Weinreb's audio conference QA Oversight of Vendor Management takes a close look at these issues, especially the challenges and success criteria of managing vendors. She provides hands-on information on how to develop, negotiate, and monitor a robust quality agreement.

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