by Robert M. Tribe
Background
This is the fourth article in a series covering different topics relating to the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The first three articles covered the following topics:
- Growth of the Pharmaceutical Inspection Cooperation Scheme1
- PIC/S Approach to Classifying GMP Deficiencies2
- Procedure for Accession to PIC/S3
As explained in these articles, PIC/S is a cooperative arrangement between 28 regulatory authorities that enables active and constructive cooperation and sharing of information in the field of GMP3.
This current article provides an update on the outcome of the meeting of the PIC/S Committee, held in Bucharest in September 2005. It also provides information on the 2005 PIC/S Training Seminar, also held in Bucharest immediately after the PIC/S Committee meeting.
PIC/S Committee Meeting, Bucharest, Romania
The PIC/S Committee, which comprises a senior representative from each of the 28 regulatory authorities that are members, met in Bucharest on 12 and 13 September 2005 under the Chairmanship of Hans Smallenbroek (of the Netherlands Inspectorate of Health Care). The main outcomes of the meeting were as follows:
1. Poland and UNICEF to join PIC/S
The Main Pharmaceutical Inspectorate (MPI) of Poland will become a member of PIC/S from 1 January 2006. This followed a detailed evaluation of the Polish Inspectorate's GMP system as well as an assessment visit to observe typical GMP inspections taking place.
The Supply Division of the United Nation's Children's Fund (UNICEF) will become an observer to PIC/S from 1 January 2005. This will enable UNICEF, one of the world's largest suppliers of vaccines, to share information and inspections reports with other PIC/S member authorities on a voluntary basis.
A full list of the 28 member authorities of PIC/S can be found on the PIC/S web site4.
2. US FDA applies for PIC/s membership
The US FDA's application to join PIC/S was received by the PIC/S Secretary on 16 September 2005. The PIC/S Committee appointed the United Kingdom's MHRA as coordinator of the assessment team which will involve six experienced assessors from different PIC/S member authorities.
3. Other countries being assessed for membership
The regulatory authorities of the following countries have already lodged applications to join PIC/S and are currently being assessed:
- Argentina
- Estonia
- Israel
- Lithuania
- Oman
- Russia
- South Africa
- Ukraine
4. Countries interested in applying for membership
The regulatory authorities of the following counties have indicated their intention to apply for PIC/S membership in the near future:
- Brazil
- Cyprus
- Indonesia
- Philippines
- Slovenia
- Thailand
5. PIC/S Blueprint
PIC/S is close to finalizing a Blueprint strategy paper which is intended to clearly define PIC/S' mission and set clear objectives and actions to be taken and achieved during the next decade (ie. by 2015). It is expected that this document will be published on the PIC/S Web site4 by the end of 2005.
6. Training of Inspectors
The topics and venues for future PIC/S Training Seminars (for GMP inspectors only) will be as follows:
- Risk Management & related ICH Issues; Düsseldorf, Germany (31 May - 2 June 2006)
- Inspection of the Manufacture of Solid Dosage Forms; Singapore (2007).
- Good Distribution Practices; Riga, Latvia (2008)
7. New GMP Guidance Documents
Three new GMP Guidance documents will enter into force on 1 January 2006 (will be made available on the PIC/S web site4 at that time). These documents are:
- Aide Memoire on the Inspection of QC Laboratories.
- Aide Memoire on the Inspection of the Manufacturer of Clinical Trial Products.
- Aide memoire on the Inspection of Biotechnology Manufacturers.
8. International Medicinal Inspectorates Database (IMID)
In order to avoid duplication with a proposed new EMEA database of manufacturers that have been inspected by European Inspectorates, due to be launched by EMEA in mid 2006, the IMID will be made dormant for the time being.
9. Elections
The Chairman of PIC/S normally serves a term of two years. The results of the elections for the new Chairman of PIC/S and other members of the Executive Bureau for the coming two years (commencing 1 January 2006) were as follows:
- Chairman J Morenas (France)
- 1st Deputy Chairman J Kurz (Austria)
- 2nd Deputy Chairman M Keller (Switzerland)
- Member E Pelkonen (Finland)
- Member P Hargreaves (UK)
2005 PIC/S Training Seminar, Bucharest
The 2005 PIC/S Training Seminar for GMP inspectors, which was held on 14-16 September, 2005 and organised by the Romanian National Medicinal Agency, covered the subject of "Primary packaging materials, labelling and the prevention of mix-ups".
The Seminar focused on:
- the training of inspectors regarding the quality, safety and security of packages used for medicinal products;
- the critical aspects to be identified and clarified regarding GMP inspection for the final stage of manufacturing process (primary and secondary packaging and labelling);
- the uniform interpretation of the GMP Guide regarding packaging of medicinal products.
The Seminar was attended by 90 participants from 38 countries, including inspectors from a number of non-member agencies, ie. Argentina, Cyprus, EMEA, EDQM, Estonia, Israel, Japan, Lithuania, New Zealand, Poland, Thailand, South Africa, Ukraine, UNICEF and US FDA.
Mr David Williams, representing ISPE, gave a presentation on "Present and Future. Influence of trends regarding packaging materials, processes, administration and security coding".
One of the outcomes of the Seminar was the formation of a Working Group to draft an Aide Memoire on the inspection of packaging materials, using material from Workshop discussions held during the Seminar.
The proceedings of the Seminar will be made available on a CD-ROM which can be purchased from the PIC/S Secretary (see PIC/S web site4)
References
- Regulatory Review Article Archives. 1 October 2004. ISPE web site (www.ispe.org).
- Regulatory Review Article Archives. 4 April 2005. ISPE web site (www.ispe.org). Pharmaceutical Engineering, November/December 2004; page 110.
- Regulatory Review Article Archives. 1 August 2005. ISPE web site (www.ispe.org).
- www.picscheme.org.
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