Supplier Audits in Pharmaceutical Environments - Did You Know?

Did You Know?

What is it that pharmaceutical manufacturers should do every 12-18 months? According to a recent FDANews update, pharmaceutical manufacturers should "conduct audits every 12 to 18 months for suppliers of critical materials," "perform a risk analysis to identify areas of concern for monitoring," and "negotiate quality agreements before signing a contract with a new supplier."

These measures are recommended during every 12-18 month interim by experts but a quote in the FDANews update from Barbara Immel, President of the regulatory consulting firm, Immel Resources, Inc., emphasizes a more important aspect of supplier management—finding and qualifying the right suppliers from the beginning. According to FDANews, Immel states: "The most effective way to ensure a good ongoing supplier relationship is to properly qualify suppliers from the start."

What can pharmaceutical manufacturers do to find and qualify good suppliers from the beginning?

According to FDANews, Immel recommends that "...manufacturers should evaluate their GMP status, technical ability and capacity for providing needed materials, and assess their business indices, such as financial stability..."

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