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With manufacturing and supply chain processes becoming more complex, critical aspects of a product are being outsourced to external global suppliers or product parts have become commodity purchases. It has become imperative that the quality of these products also meet regulatory requirements.

A recent example, for the COVID-19 vaccine, over 30 Contract Manufacturing Organizations (CMOs) are being used by vaccine developers to manufacture enough vaccines to meet global demand. Considering that the vaccine will be developed by small, mid-size and large companies, contract manufacturers must make sure they meet regulatory compliance requirements to mitigate risk to patient safety. Of course, regulatory compliance and quality metrics, ideally, must not delay time to market. A well-designed Supplier Quality Agreement plays a crucial role in ensuring this compliance.

Challenges to Implementing a Foolproof Supplier Quality Agreement (SQA)

SQA is one of the most important documents and it is an investment for companies to ensure that it is created properly to include various elements that are business-specific. Despite a clear mandate from the regulatory bodies, gaps continue to exist in the implementation. Some of the reasons include,

  • Confusion between ‘supply agreement’ and ‘supplier quality agreement’
  • A key supplier refuses to sign the contract
  • One size does not fit all
  • Review and/or revisions are not scheduled
  • Training requirements not met
  • Poor document management
  • Capability review and audit related issues

This whitepaper provides in-depth expertise into the world of SQAs to help you ensure world-class supplier quality.

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