Good Manufacturing Practice (GMP) certifies that medicinal products are regularly produced and controlled to the quality standards relevant to their purposeful use or as required for marketing clearance.
In alignment with the Access Consortium’s strategic purpose to expand and maximise cooperation throughout the product lifecycle, this joint statement issued by the Access Heads of Agencies serves to congeal the Consortium’s commitment to exhibit greater inspection reliance and accept GMP inspection outcomes.
The dependence on inspection outcomes will be based on reviewing inspection reports or other documentary evidence for GMP reviews performed by Access members within their territory instead of performing another GMP inspection. It eases the regulatory burden on stakeholders and could facilitate our populations’ timely access to high-quality, safe and useful pharmaceutical products.
Establishing such arrangements reduces the repetition of GMP inspections and allows for more efficient use of each authority’s resources, permitting these to be channelled to areas where most required.
The Access Consortium will continue to explore possibilities for information and work-sharing initiatives to align the regulatory systems better, reduce unnecessary duplication and streamline convergence.
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