Experts: Regular Supplier Audits, Quality Agreements Are Key

Manufacturers should conduct audits every 12 to 18 months for suppliers of critical materials, such as active pharmaceutical ingredients, perform a risk analysis to identify areas of concern for monitoring, and always should negotiate quality agreements before signing a contract with a new supplier, experts say.

The most effective way to ensure a good ongoing supplier relationship is to properly qualify suppliers from the start, Barbara Immel, president of regulatory consulting firm Immel Resources, said.

Before contracting with new suppliers, manufacturers should evaluate their GMP status, technical ability and capacity for providing needed materials, and assess their business indices, such as financial stability, she said.
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