PIC/S UPDATE: PIC/S Committee Meeting, May 2007

by Robert M. Tribe

BACKGROUND
PIC/S, the Pharmaceutical Inspection Cooperation Scheme, is a cooperative arrangement between 30 regulatory authorities that enables active and constructive cooperation and sharing of information in the field of GMP¹. A full list of the 30 member authorities of PIC/S is shown at the end of this article².

This article provides an update on the outcome of the meeting of the PIC/S Committee held in Geneva, Switzerland on 15 – 16 May 2007.

PIC/S COMMITTEE MEETING, GENEVA, SWITZERLAND
The PIC/S Committee, which comprises a senior representative from the GMP Inspectorate of each of the 30 member authorities, met in Geneva, Switzerland on 15 – 16 May 2007 under the Chairmanship of Jacques Morénas (of the French Agency for the Safety of Health Products - AFSSAPS). The main outcomes of the meeting were as follows:

1. South Africa and Argentina to Join PIC/S:
Following detailed PIC/S assessments of the system of GMP controls and inspections of South Africa’s Medicines Control Council (MCC) and Argentina’s National Institute of Medicaments (INAME), these regulatory authorities were invited to become members of PIC/S from 1 July 2007 and 1 January 2008 respectively. This will bring the total number of authorities that are members of PIC/S to 32.

2. France’s Agency for Veterinary Medicinal Products applies to join PIC/S:
France’s Agency for Veterinary Medicinal Products (AFSSA – ANMV) applied to join PIC/S in December 2006. A Rapporteur was nominated to assess this application.

3. Status of membership applications of other regulatory authorities:
The membership applications of the following regulatory authorities were reviewed as follows:

USA’s Food and Drug Administration (US FDA): The US FDA application was reviewed and continues to be active.
Lithuania’s State Medicines Control Agency (SMCA):
The SMCA application was reviewed and continues to be active.
Israel’s Ministry of Health:
The Committee appointed a delegation to undertake an assessment visit to review the system of GMP controls and inspections followed by Israel’s Ministry of Health.
Thailand’s Food and Drug Administration (Thai FDA):
The Committee appointed a delegation to undertake an assessment visit to review the Thai FDA system of GMP controls and inspections.

4. Reassessment of PIC/S member authorities:
The partial reassessment of Iceland’s Medicines Control Agency (IMCA) had revealed that IMCA met all PIC/S requirements.

5. Cooperation with other organizations:
The Committee noted that EMEA had replied favorably to a PIC/S proposal to strengthen the cooperation between the two organizations. The proposed fields of cooperation would include the training of inspectors, the participation in meetings, the exchange of information and the evaluation/re-evaluation of competent authorities.

WHO’s Immunization, Vaccines & Biologicals (IVB) Department agreed in principle to develop an informal cooperation with PIC/S.

6. Exchange of Information:
The Committee agreed to a proposal to revise the PIC Scheme³ to better clarify the scope and methods relating to the exchange of information between member authorities. Members of the Committee also agreed to better share information on GMP inspections, including:

sharing forward inspection plans in order that member authorities had information on sites and products to be inspected in the future by other member authorities;
agreeing in principle to carrying out “team inspections.”

7. Training for Inspectors:
The Committee noted that the PIC/S Working Group on the Training of Inspectors had met in Geneva on the morning of 15 May 2007. This Working Group:

noted that the PIC/S “Joint Visits Program” had been opened to GCP (Good Clinical Practice) inspections;
reviewed the program for the 2007 PIC/S Training Seminar to be held in Singapore on “Inspection of Solid Dosage Forms”;
discussed the organization of the 2008 PIC/S Training Seminar on GDP (Good Distribution Practice) to be held in Krakow, Poland;
reviewed the activities of the different PIC/S “Expert Circles.”⁴

8. Guidance Documents:
The Committee noted the following:

The PIC/S GMP Guide (PE 009-6) had recently been revised (issued on 6 April 2007)⁵ as follows:
- Part 1 (covering GMP principles for the manufacture of medicinal products)
- Part 2 (covering GMP for active substances used as starting materials)
- Annexes 1 to 19 (Annex 19 is a new Annex covering Reference and Retention Samples)
The “Explanatory Notes for Industry on the Preparation of a Site Master File” would be revised.

9. Other Business:
The Committee agreed on the following:

The two-year Chairmanship of Jacques Morénas (of AFSSAPS, France) would be extended by one year, until the end of 2008.
Michel Keller (of Swissmedic, Switzeraland) was elected as First Deputy Chairman and Tor Gråberg (MPA, Sweden) was elected as Second Deputy Chairman for the period 2007-2008.
The next meeting of the Committee would take place in Singapore on 19 November 2007.

REFERENCES:

Regulatory Review Article Archives. 1 August 2005. ISPE web site (www.ispe.org).
The 30 regulatory authorities that are members of PIC/S come from: Australia, Austria, Belgium, Canada, Czech Republic (both Human and Veterinary), Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland, and the United Kingdom.
Document “PIC/S 1/95 (Rev. 3)”. Available at the “Publications” page of the PIC/S web site (www.picscheme.org/index.php?p=miscel).
“Expert Circles” are described within the “Role & Functions” page of the PIC/S web site (www.picscheme.org/index.php?p=role).
PIC/S Guide to Good Manufacturing Practice for Medicinal Product, Document “PE 009-6, 5 April 2007”. Available at the “Publications” page of the PIC/S web site (www.picscheme.org/index.php?p=guides).