Membership & US Entry, GDPs, QRM Guidance and Traditional/Herbal Medicine Inspections Draw PIC/S Attention

FDA’s entry into the Pharmaceutical Inspection Cooperation Scheme (PIC/S) at the beginning of 2011 will be marked by the participation of Commissioner Margaret Hamburg at PIC/S’ upcoming 40th anniversary symposium on “Challenges and Future Perspectives” in Geneva, Switzerland in late May.

Hamburg will give the keynote address at the symposium.  The symposium and adjoining meeting represents FDA’s initial participation in PIC/S as a full member.

FDA was cleared to join the 37 other participating agencies in PIC/S at its November gathering in Kuala Lumpur, Malaysia following a five-year evaluation period made more difficult by the complexity of FDA’s organization structure.

A focused mid-2010 effort by a cross-organizational FDA team and a positive revisit from PIC/S in August cleared the way for the acceptance (see IPQ “In the News” Sept. 27, 2010 for a review of the FDA application and assessment process as well of PIC/S’ history, role and function, accession procedure, and current guidance development, training, seminar and quality system activities.)

Ukraine’s State Inspectorate for Quality Control of Medicines (SIQCM) was also cleared for membership at Kuala Lumpur beginning in 2011. The Ukraine agency had submitted its application in 2004, a year before FDA. The acceptance followed on-site PIC/S evaluation visits in March and October.

[An update on PIC/S initiatives related to membership, good distribution practices, quality risk management and traditional/herbal medicine inspections is provided for subscribers here. Non-subscribers can purchase the full story for $95 by contacting Jonathan Trethowan (  For subscription information click here.  An analysis of the revision of PIC/S’ site master file guide for industry, which was approved at the Malaysia meeting, is provided in the companion “In the News” story also posted December 29.]