Access Consortium statement on Good Manufacturing Practice inspections reliance and recognition evidence
Date: November 21, 2022
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Background
Good manufacturing practice (GMP) ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use or as required for marketing authorization.
The Access Heads of Agencies have issued a collective statement that:
- aligns with the Consortium’s strategic objective to expand and maximize collaboration through the life cycle of a product
- solidifies the Consortium’s commitment to demonstrate greater inspection reliance and accept GMP inspection outcomes
The reliance on inspection outcomes will be based on the review of inspection reports for GMP inspections conducted by Access members within their territory, in lieu if conducting another GMP inspection. The purpose of this is to:
- reduce the regulatory burden on stakeholders and
- facilitate timely access to high quality, safe and effective pharmaceutical products
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Commitment to reliance and recognition arrangements
GMP inspection reliance arrangements and formal mutual recognition arrangements are highly effective tools. They can help regulatory authorities manage increasing complexity in the manufacturing and supply chain of medicines in a timely manner. Establishing such arrangements reduces duplication of GMP inspections and allows for more efficient use of each authority's resources. Each authority will thus be able to channel resources to areas where most needed.
As participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Access members will commit to accept GMP inspection reports issued by Access members for GMP inspections conducted within their territory instead of conducting another GMP inspection. The Consortium will:
- maximize the existing GMP inspection reliance and mutual recognition agreements in place and
- work closely together to expand their use wherever possible for products undergoing evaluation
The Access Consortium will continue to explore opportunities for information and work-sharing initiatives. Our goal is to better align the regulatory systems, reduce unnecessary duplication and facilitate greater reliance.
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