Ensuring GxP Compliance for Supplier Quality Management: A Life Science Perspective

Under current regulatory requirements, the life science industry must ensure quality systems are put in place and updated on a consistent basis for suppliers involved in the development of new products. Recently, life science companies from pharmaceutical, biotech and medical device industries gathered at the IVT Premier Life Sciences Forum for 3 days of discussions on the latest industry standardization, regulations and best practices for managing supplier audits. Workshop attendees reviewed case scenarios and real-life examples to identify best practices for developing supplier quality management standards for processes and contracts. Key topic discussed during the 3 day conference included:

A look at the current regulatory climate –Margaret Hamburg, FDA commissioner stated recently that “companies that sell contaminated products because of loose supply chain oversight need to face serious penalties … and cannot excuse themselves by blaming their suppliers, blaming the FDA or blaming anyone else ”.  It appears that the FDA is stepping up its efforts, moving from a system that places most of the regulatory burden on the FDA’s modest inspection force, to one that creates greater oversight at points further back along the production chain. The commissioner further stated that addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of her highest priorities for FDA. The EU’s requirements were also discussed in length specifically around variances from FDA regulations.

Expectations for oversight, documentation and corrective action stemming from supplier audits – attendees discussed latest directives for medical device and pharmaceutical companies and how those impact the way companies manage their supply chain -  specifically areas of focus in supplier audits. Key questions discussed revolved around the ongoing challenge of “who should be audited”, “how often”, “how to prepare” and “what to look for during a supplier audit.”

Evolution of supplier management philosophy – traditional concepts of device or manufacturing level verification and auditing are shifting rapidly to ensuring quality control at the source. Companies can no longer count solely on quality control on their end. Together with a risk based approach, the onus is on companies to proactively pursue quality with their suppliers where the source of the product(s) originates.

Conclusion: Suppliers are critical to the success of life science organizations, however companies must manage the quality of their supply base to compete and avoid issues. Transition from primarily quality system audits to process audits, as well as greater regulatory focus on supplier controls is driving greater focus on suppliers.

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