FDA TO JOIN PIC/S TO WORK TOWARD GMP HARMONIZATION

The U.S. FDA has applied to join the Pharmaceutical Inspection Cooperation Scheme, an international good manufacturing practices (GMP) initiative, to work toward harmonizing global GMP standards. The move is part of the FDA's 21st Century Drug cGMP Initiative.

The Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperation Scheme (jointly referred to as PIC/S) comprise international pharmaceutical inspection authorities. PIC/S currently has 29 members, mainly in Europe.

The PIC/S mission is to lead the international development, implementation and maintenance of harmonized GMP standards and quality systems by developing and promoting standards and guidance documents, training competent authorities, assessing inspectors and facilitating cooperation and networking among international organizations. The main goal is more harmonized and predictable inspections, which are achieved through best practices guides, inspection guides and a structured training program.