PIC/S Update: Committee Meeting & PIC/S-Industry Forum

by Robert M. Tribe

Background
PIC/S, the Pharmaceutical Inspection Cooperation Scheme, is a cooperative arrangement between 29 regulatory authorities that enables active and constructive cooperation and sharing of information in the field of GMP1. A full list of the 29 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 21 – 22 November 2006. It also provides information on the first PIC/S – Industry Forum held on 23 November 2006, at which ISPE was represented.

PIC/S Committee Meeting, Geneva, Switzerland
The PIC/S Committee, which comprises a senior representative from each of the 29 member authorities, met in Geneva on 21 – 22 November 2006 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. Estonia to Join PIC/S:
Following a lengthy assessment by PIC/S, Estonia’s State Agency of Medicines (SAM) has been invited to become a member of PIC/S from 1 January 2007. On that date, SAM will become the 30th regulatory authority to be a member of PIC/S.

2. Malta applies to join PIC/S:
Malta’s Medicines Authority applied to join PIC/S in October 2006. A Rapporteur was nominated to assess Malta’s application.

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

US’ Food and Drug Administration (US FDA):
A representative from the US FDA made a presentation of their GMP inspection system. The Committee noted that the Rapporteur for the US FDA had prepared a list of questions to be addressed by the US FDA.
Lithuania’s State Medicines Control Agency (SMCA):
A representative from SMCA made a presentation of their GMP inspection system.
Argentina’s National Institute of Medicaments (INAME):
INAME’s application was reviewed. The Committee noted that a PIC/S assessment visit to Argentina had been scheduled to take place on 27 November to 1 December 2006.
South Africa’s Medicine Control Council (MCC):
MCC’s application was reviewed. The Committee noted that a PIC/S assessment visit in South Africa took place in September 2006 and a report of that visit was pending.
Israel’s Ministry of Health:
The Committee was informed on the progress being made by Israel’s Ministry of Health as well as the expected timing of the PIC/S assessment in Israel.
Thailand’s Food and Drug Administration (Thai FDA):
The Committee was informed on the progress being made by the Thai FDA. A preliminary visit by the PIC/S Chairman to the Thai FDA was to take place on 2 December 2006.

4. Reassessment of PIC/S member authorities:
In relation to reassessments of PIC/S member authorities the Committee noted:

The reassessment of Greece’s National Organization for Medicines (EOF) had been finalized and closed.
The report of the reassessment of United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) was still pending.
Reassessments of Iceland’s Medicines Control Agency (IMCA), Switzerland’s Agency for Therapeutic Products (Swissmedic) and Liechtenstein’s Kontrollstelle für Arzneimittel (KA) had been launched.
A reassessment of the new competent authority in Austria, AGES PharmMed, was to take place after 1 January 2007 when this authority would commence operating. The reassessment team would comprise inspectors from Germany, Italy and Switzerland.

5. Cooperation with other organizations:
The Committee adopted new Guidelines on Partnership replacing the Guidelines on PIC/S Observer Status. The Guidelines introduce the status of “Associate Partner” (replacing the current status of “Observer”) and the concept of “Non-Binding Partnership,” which aims at defining areas of cooperation between PIC/S and the Associated Partner.

The PIC/S Chairman updated the Committee on his visits to EMEA (European Medicines Evaluation Agency), DG SANCO (European Commission’s Health & Consumer Protection Directorate-General), DG Enterprise (European Commission’s Enterprise & Industry Directorate-General) and EDQM (European Directorate for the Quality of Medicines). The outcomes of the visits were positive, especially in terms of coordination of training activities with the EMEA and EDQM.

6. 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 21 November 2007. This Working Group:

reviewed the activities of the PIC/S Joint Visit Programme (JVP): 25 groups are active and seven have completed their cycle;
discussed PIC/S guidelines on coached inspections;
o reviewed the evaluation of the 2006 Seminar in Düsseldorf on Quality Risk Management and related ICH Topics;
reviewed the program of the 2007 PIC/S Seminar in Singapore on the Inspection of Solid Dosage Forms;
discussed the organization of the 2008 Seminar on GDP (Good Distribution Practice) in Krakow (Poland) and the 2009 Seminar on Herbal Medicines (venue to be decided);
reviewed the objectives of all PIC/S Expert Circles for 2007.

The Committee approved the establishment of a new Expert Circle on Quality Risk Management in order to train Inspectorates in this particular field starting with ICH Q9. This Expert Circle will be open to experts form the EU, Japan, and the US.

7. Guidance Documents:
The Committee noted that the second draft of the PIC/S Guide to Good Practices for Preparation of Medicinal Products in Pharmacies had been released for consultation to national and international hospital and pharmacy associations (obtainable from PIC/S web site3).

8. Other Business:
The Committee:

adopted the 2007 Budget and selected an external financial auditor to audit the 2006 accounts;
re-elected Eija Pelkonen (National Agency for Medicines, Finland) as Member of the Executive Bureau for the period 2007-2008;
agreed on the principle to have a joint PIC/S – ISPE Workshop in Singapore on Quality Risk Management, in conjunction with the 2007 PIC/S Seminar (20-22 November 2007);
revised the first version of an Information Brochure on PIC/S;
decided that the next meeting would take place in Geneva (Switzerland) on 15-16 May 2007.

First PIC/S - Industry Forum
On 23 November 2006 PIC/S met for the first time with representatives of international industry and professional associations, i.e. EFPIA, FIP, IFPMA, ISPE and PDA. PIC/S was led by a Delegation involving the Chairman of PIC/S, Jacques Morénas.

The meeting aimed at exchanging information and identifying possible areas of co-operation in terms of GMP (e.g. training).

The main operational conclusions from the meeting were:

1. On GMP Training:

PIC/S and Industry to exchange information on training programs in advance (6 months at least).
Industry associations to encourage manufacturers to provide training material to PIC/S in the form of short videos or photos on a particular stage (e.g. granulation) of the manufacturing process of solid dosage forms, which is the topic of the 2007 PIC/S Seminar in Singapore.
Industry associations to encourage manufacturers to provide concrete cases / good examples on the implementation by industry of Quality Risk Management (QRM).
PIC/S and industry associations to explore the possibility to develop training based on one scenario (e.g. on QRM) to be looked at by inspectors and industry in separate sessions with common feed-back/discussion at the end.
Industry to facilitate visits ("walk around") of manufacturing sites by PIC/S Inspectorates, e.g. to present positive and negative aspects of a new technology, to familiarize (junior) GMP inspectors with a particular manufacturing process, etc.
Industry associations to make it possible for PIC/S inspectors to "anonymously" take part in professional training without being "pinned down" with questions.
PIC/S to discuss to organize back-to-back meetings with industry & professional associations.

2. On GMP Inspections:

Industry associations to encourage companies to be more pro-active:
- by informing PIC/S Inspectorates on the last/forthcoming inspection by another Inspectorate;
- by spontaneously submitting the last inspection report;
- by fixing across the board (in the entire manufacturing site/other sites) deficiencies noted by an inspector in one particular spot;
- by ensuring the commitment of the company’s top management to GMP;
- by encouraging non-PIC/S Authorities to join PIC/S.
PIC/S to consider better ways to share/use information on inspections.
PIC/S to discuss the possibility of “team inspections” by several PIC/S Participating authorities.

References:
1. Regulatory Review Article Archives. 1 August 2005. ISPE web site (www.ispe.org).
2. The 29 regulatory authorities that are members of PIC/S come from:
Australia, Austria, Belgium, Canada, Czech Republic (both Human and Veterinary), Denmark, 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.
3. http://www.picscheme.org