After five years of discussions, the US Food and Drug Administration is joining the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), known together as PIC/S. The agency submitted its application in September 2005 and will be an official member as of Jan. 1, 2011.
PIC was established in 1970 and the Scheme was launched in 1995. Together, the two bodies serve as the foremost international collaborative body on pharmaceutical manufacturing inspections and as a major supporter of GMP training and harmonization. The organization, which now has 39 members, functions as a cooperative arrangement among global regulatory and health authorities. Other PIC/S activities and benefits are listed on the organization’s website.
The PIC/S Audit team gave FDA an approval during a follow-up visit to the agency’s Silver Spring, Maryland, headquarters in August 2010. In November 2010, at the organization’s leadership meeting in Malaysia, FDA’s accession to PIC/S was formally accepted. The Ukraine’s State Inspectorate for Quality Control of Medicines is also becoming a new member as of January 2011.
According to the PIC/S website, the application-review process includes a detailed assessment to determine whether the regulatory authority is able to apply an inspection system comparable to that of current PIC/S members. The assessment involves “an examination of the authority’s GMP inspection and licensing system (or equivalent), quality system, legislative requirements, inspector training, etc. It is followed by a visit by a PIC/S delegation to observe in particular inspectors carrying out routine GMP inspections.” The full guidelines for joining PIC/S are here.
It typically takes two to three years for a membership application to be completed, with a maximum allowable timeframe of six years. Many European regulatory authorities are members. The European Medicines Agency, European Directorate for the Quality of Medicines, UNICEF, and World Health Organization are partners with PIC/S. Of interest, the regulatory agencies of Japan, China, and India are not yet members.
In November 2007, former FDA Commissioner Andrew C. von Eschenbach noted to Congress that the agency was in the process of joining PIC/S to ultimately “enable the exchange of inspection reports and other inspection information with regulatory authorities.” It’s hoped that PIC/S membership will help fill a gap in the number of overseas inspections conducted by FDA.
The PDA website provides a detailed look at FDA’s application process with PIC/S.
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