June 2006 - PIC/S Update: Dusseldorf Committee Meeting and Seminar

Background

The Pharmaceutical Inspection Cooperation Scheme, (PIC/S), is a cooperative arrangement between 29 regulatory authorities that enables active and constructive cooperation and sharing of information in the field of GMP. A full list of the 29 member authorities of PIC/S is shown at the end of this article.

This article provides an update on the outcome of the meeting of the PIC/S Committee held in Düsseldorf, Germany in May 2006. It also provides information on the 2006 PIC/S Training Seminar held in Düsseldorf immediately after the PIC/S Committee meeting.

PIC/S Committee Meeting, Düsseldorf, Germany

The PIC/S Committee, which comprises senior representatives from each of the 29 member authorities, met in Düsseldorf on 29 and 30 May 2006 under the Chairmanship of Mr. Jacques Morénas of the French Agency for the Safety of Health Products. The main outcomes of the meeting were as follows:

Thailand Applies to Join PIC/S
Thailand's Food and Drug Administration (Thai FDA) applied to join PIC/S on 24 February 2006. Representatives from the Thai FDA made a presentation about the system of GMP controls in Thailand and answered questions raised by members of the Committee. It was agreed that the Chairman of PIC/S would visit the Thai FDA at the end of 2006 to discuss its membership application.
Membership Applications of other Regulatory Authorities
The membership applications of the following regulatory authorities were reviewed in the presence of representatives from these authorities:
- Argentina's National Institute of Medicaments (INAME):
  Following a detailed assessment of INAME's systems of GMP controls, an assessment visit has been scheduled to take place in September 2006. During this visit the GMP controls will be further assessed at the headquarters of INAME and a series of typical GMP inspections will be observed.
- South Africa's Medicine Control Council (MCC):
  Following a detailed assessment of MCC's systems of GMP controls, an assessment visit has been scheduled to take place in November 2006. During this visit the GMP controls will be further assessed at the headquarters of MCC and a series of typical GMP inspections will be observed.
- USA's Food and Drug Administration ( US FDA):
  The assessment of the US FDA's application by the assigned Rapporteur and Co-Rapporteur is still underway.
- Estonia's State Agency of Medicines (SAM):
  A follow-up assessment visit to Estonia will be carried out later in 2006
Reassessment of PIC/S Member Authorities
The UK's Medicines Healthcare Products Regulatory Agency (MHRA) was recently reassessed by a PIC/S team and the report of the reassessment visit is close to being finalized.

It was decided that the reassessments of Iceland's Medicines Control Agency (IMCA), Switzerland's Agency for Therapeutic Products (Swissmedic) and Liechtenstein's "Kontrollstelle fûur Arzneimittel" (KA) will be based on assessments to be carried out shortly by Health Canada as part of its ongoing monitoring of Mutual Recognition Agreement (MRA) partners.

It was decided to reassess Austria following the creation of a new competent authority, the Austrian Medicines and Medical Devices Agency (AGES PharmMed).

It was decided to reassess Australia's Therapeutic Goods Administration (TGA) once it merged with New Zealand's Medicines and Medical Device Safety Authority (Medsafe) and the new Agency became effective 1 July 2007. The new joint Australia/New Zealand Agency is to be known as the "Australia New Zealand Therapeutic Products Agency" (ANZTPA).
Training for Inspectors
The program for the 2007 PIC/S Training Seminar on "Inspection of the Manufacture of Solid Dosage Forms" to be held in Singapore on 21-23 November 2007 was discussed. ISPE is providing a presenter for this Seminar.

It was decided that the 2008 PIC/S Seminar would be held in Poland on the subject of Good Distribution Practices (GDP).

In relation to Expert Circles (meetings to enable specialist inspectors to discuss and exchange information on specific technical areas of GMP), it was agreed that the notion of "expert" would be defined. Proposed meeting dates for Expert Circles on Computerized Systems, Hospital Pharmacy, Human Blood and Tissue, and Active Pharmaceutical Ingredients were reviewed. It was agreed to form a new Expert Circle group on GDP and to suspend the Expert Circle on Medicinal Gases. The work of this Expert Circle has included the finalization of the PIC/S Aide-Memoire on Medicinal Gases; which will be made available on the PIC/S Web site ⁴.
PIC/S GMP Guide
It was agreed that the format of the PIC/S GMP Guide would be revised in line with the EU GMP Guide, i.e., Chapters 1 to 9 would become Part I, while the PIC/S GMP Guide on APIs would become Part II of the revised PIC/S GMP Guide.

It was noted that additions to Chapter 6 of the PIC/S GMP Guide, covering "Ongoing Stability Monitoring," and the adoption of a new Annex 19, covering "Reference Samples and Retention Samples," entered into force on 1 June 2006 and will be made available on the PIC/S Web site ⁴.
Relations with Other Organizations
It was agreed to hold a half-day meeting with industry and professional associations in Geneva, Switzerland, on 23 November 2006, the day after the next meeting of the PIC/S Committee. ISPE will be represented at this meeting.
PIC/S Blueprint
It was noted that the PIC/S Blueprint has been successfully adopted. This document is intended to clearly define PIC/S' mission and set clear objectives and actions to be taken and achieved during the next decade (i.e., by 2015).

2006 PIC/S Training Seminar, Düsseldorf

The 2006 PIC/S Training Seminar for GMP inspectors, which was held on 31 May to 2 June 2006 and organized by the German Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices (ZLG), covered the subject of "Quality Risk Management and related ICH Topics."

The Seminar focused on:

the ICH process
ICH Q8 "Pharmaceutical Development" from both regulators' and industry's perspective
ICH Q9 "Quality Risk Management" from both regulators' and industry's perspective
the progress made in the development of ICH Q10 "Quality Systems" and its future use by industry

the interaction and the complementarity of these three topics as a common framework

The Seminar was attended by 110 participants from 39 countries, including inspectors from a number of non-member agencies, including Argentina, Croatia, Cyprus, EMEA, Estonia, Israel, Japan, Lithuania, New Zealand, Poland, Taipei, Thailand, Serbia, South Africa, and, the USA.

The proceedings of the Seminar will be made available on a CD-ROM which can be purchased from the PIC/S Secretary.

Further details on this update can be obtained from the June 2006 PIC/S Press Release on the PIC/S Web site.

References

Regulatory Review Article Archives. 1 August 2005. ISPE Web site (www.ispe.org).
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.
www.anztpa.org
www.picscheme.org
Regulatory Review Article Archives. March 2005. ISPE web site ( www.ispe.org).