IFPMA Position on Convergence of Good Manufacturing Practice (GMP) standards and Related Inspections
This position paper reiterates the global industry position on GMP convergence (June 2017 position paper and addresses the ICDRA WHO recommendations to industry with regard to the sharing of inspections information amongst regulators and procurement agencies under the Reliance approach.
- Good Manufacturing Practice (GMP) , Good Distribution Practice (GDP) standards and associated inspections are important components of strong regulatory systems, and contribute to ensuring that pharmaceutical products are manufactured to high quality standards to supply patients worldwide.
- IFPMA recognizes and supports the efforts undertaken by National Regulatory Authorities (NRAs) to advance convergence and cooperation at regional and international level; achievements to date are described in the ICMRA mapping
- IFPMA further encourages processes to strengthen the overall regulatory system, optimize regulatory oversight by authorities, avoid duplication and redundancy and contribute to facilitating reliable global supply chains.
- Thus, IFPMA proposes approaches on GMP/GDP standard convergence, aligned inspection processes and NRA cooperation, as follows.