FDA Obtains Sought-After PIC/S Membership

On Jan. 1, 2011, the US Food and Drug Administration Good Manufacturing Practice (GMP) Inspectors became part of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) family of GMP inspectors. FDA was invited to join as a Participating Authority at the joint meeting of the PIC/S Committee of the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) held in Malaysia last November.

Following the announcement of the invitation, Brenda Holman, executive director of strategic initiatives for FDA's Office of Regulatory Affairs (ORA), said, "One agency cannot inspect the whole world—we need collaboration and harmonization."

Background and application process

FDA embarked on its long process toward PIC/S membership in June 2005 by submiting a formal application. The PIC/S assessement of FDA's application, led by an appointed rapporteur, focused on reviewing and evaluating the agency's GMP inspectorate quality system. In addition, a five-member delegation (representing five continents) from PIC/S conducted two assessment visits. The first visit, which lasted two weeks, included an assessment of the quality management system (QMS) at FDA headquarters as well as observation of two local GMP inspections. The second visit lasted one week and involved additional time at agency headquarters.

Following the initial assessment visit, it was apparent to the PIC/S team that easy implementation of a QMS across FDA headquarters and its national field offices was hampered by the complexity and enormity of FDA operations. For example, the ORA office, which is responsible for inspections, has more than 3000 employees.

The first assessment report issued by PIC/S in January 2010 identified gaps on approximately one quarter of the PIC/S indicators. There are 89 indicators contained in the PIC/S audit checklist (see www.picsheme.org/accession.php for the list).

The FDA team involved in the application process worked diligently to meet PIC/S expectations and evaluation criteria before the assessment team's second visit in August 2010. The entire evaluation process of FDA took approximately 5 years. PIC/S has a maximum 6-year review period.

Benefits of PIC/S membership

Drug regulatory authorities worldwide are faced with the reality of globalization, increased cross-border trade, counterfeit drugs marketed within and between countries, and constant progress and evolution in science and technology. Globally, significant resources are committed to actively support efforts to expand access to medicines in accordance with the leadership responsibilities of national governments and international regulatory agencies. PIC/S is designed to assist national regulatory authorities in strengthening their GMP inspectorate and regulatory standards.

PIC/S membership allows increased transparency and visibility of inspections performed by participating authorities, reduces multiple inspections of the same drug product or API manufacturing sites by different participating regulatory authorities, and increases the number of sites inspected globally. Membership enables more manufacturing sites to be monitored and reduces unnecessary duplication of inspections by national authorities. For example, inspection schedules are shared to identify sites of common interest. In addition, inspection coverage is coordinated in a manner that joint inspections can be performed, resulting in the more efficient use of resources and better harmonization of GMP guidelines, deficiency classification, and post-inspection communication of outcomes. Finally, members gain access to educational opportunities via joint-visits programs (this training program allows inspectors from different countries to observe others to determine similarities and differences in practice and interpretation of inspection routines), coach inspections, and PIC/S seminars and expert circles.

As the global pharmaceutical industry expands, collaboration is vital to regulators trying to oversee greater numbers of complex, multisite supply chains. However, it is acknowledged that GMP recommendations and legislation alone do not determine the success of quality assurance in practice. Quality (as a concept) and GMP compliance by the pharmaceutical industry are also dependent on effective implementation, appropriate enforcement, and a common interpretation and understanding of the GMP principles by the national regulatory authority's GMP inspectorate teams and by the regulated industry.

Joey Gouws is deputy registrar/director, Inspectorate and Law Enforcement, for South Africa's National Medicines Regulatory Authority, and second deputy chair of PIC/S.