PIC/S UPDATE: December 2007

by Robert M. Tribe

BACKGROUND

PIC/S, the Pharmaceutical Inspection Cooperation Scheme, is a cooperative arrangement between 31 regulatory authorities that enables active and constructive cooperation and sharing of information in the field of GMP ¹. A full list of all member authorities of PIC/S is shown at the end of this article ².

A number of PIC/S activities took place in Singapore during the week of 19 – 23 November 2007, including a joint ISPE-PIC/S Workshop on “Systems Approach to Quality Risk Management” involving both regulators and industry participants. PIC/S activities prior to this Workshop included a meeting of the PIC/S Committee, a training Seminar for GMP inspectors, and a meeting with ASEAN regulatory authorities.

This article provides a summary of the outcomes of all these activities.

ISPE-PIC/S WORKSHOP ON “SYSTEMS APPROACH TO QUALITY RISK MANAGEMENT”: SINGAPORE, 22 – 23 November 2007

ISPE joined with PIC/S to co-host this Workshop, which was the first time that PIC/S had collaborated with an industry organization to arrange the training of regulatory GMP inspectors alongside industry representatives.

The Workshop was attended by 226 participants, comprising 65 regulators and 161 industry participants from 34 different countries. The Workshop provided updates on ICH Q8, Q9, and Q10, as well as the risk management methodologies that the industry can use to enhance manufacturing efficiencies. Examples of the use of risk management approaches, in the form of actual case studies, were presented by a French regulator and an industry representative.

Regulators and industry representatives also worked together in small breakout groups to discuss and seek solutions to two fictitious manufacturing problems using risk management tools and methodologies. These workshop exercises revealed that regulators and industry generally reached similar conclusions when solving manufacturing problems, using similar risk management approaches.

There was enthusiastic participation and interaction between regulators and industry, not only during the Workshop sessions but also during the less formal coffee and lunch breaks and evening networking reception.

PIC/S has reported in its Press Release ³ that “the Workshop was a success and it is expected that more joint workshops will be organized with professional and industry associations in the future.”

Bruce Davis, Chairman of ISPE, has indicated, “We in ISPE were proud to have been the first industry organization to be invited to co-host such a prestigious event in such a dynamic part of the world and, as Chairman, I was delighted to be able to open the Workshop along with Mr. Jacques Morénas, Chairman of PIC/S.”

The presentations given at the Workshop can be downloaded from the ISPE Web site (ISPE Members only).

PIC/S COMMITTEE MEETING: SINGAPORE, 19 November 2007

The PIC/S Committee, which comprises a senior representative from the GMP Inspectorate of each of the 31 member authorities, met in Singapore on 19 November 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:

Status of Membership Applications:
- Argentina's National Institute of Medicaments (INAME) will become a member of PIC/S on 1 January 2008 following an assessment visit in late 2006 and follow-up on specific issues.
- Malta's Medicines Authority (MMA) will become a member of PIC/S on 1 January 2008 based on assessment reports from Canada and the European Union which both evaluated Malta in the framework of their MRA (mutual recognition agreement).
- On-site assessment visits of Israel's Ministry of Health, Thailand's FDA and France's Agency for Veterinary Medicinal Products will take place during 2008.
- Cyprus' Pharmaceutical Services applied to join PIC/S in November 2007. The competent authorities of New Zealand and Indonesia have indicated their intention to apply for PIC/S membership in 2008.
- The Committee reviewed the progress made in the assessment of the application submitted by the US FDA.
Training of Inspectors:
- The program for future training Seminars for inspectors will be as follows:
  - GDP (Good Distribution Practice) for APIs and medicinal products; Krakow, Poland, May 2008.
  - Sterile Aseptic Manufacturing for APIs and medicinal products; Uppsala, Sweden, 2009.
  - Herbal Medicines; Malaysia, 2010.
- Five different Expert Circle meetings ⁴ were held in the latter part of 2007 as follows:
  - Expert Circle on Hospital Pharmacy ( Oslo, Norway, 25-27 June 2007)
  - Expert Circle on Quality Risk Management ( Paris, France, 2-3 July 2007)
  - Expert Circle on APIs (Paris, France, 12-14 September 2007)
  - Expert Circle on Computerised Systems ( Dublin, Ireland, 1-3 October 2007)
  - Expert Circle on Human Blood and Tissue ( Dublin, Ireland, 1-5 October 2007)
Guidance Documents:
- The Committee adopted the final draft of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products. This Guide will present the basic requirements for the preparation of medicinal products by healthcare establishments for direct supply to patients. It will shortly be available on the PIC/S Web site after final editing.
Relations with other Organizations:
- An MOU (Memorandum of Understanding) between PIC/S and EMEA covering the training of GMP inspectors, the exchange of information on guidance documents, and audits of GMP inspectorates is expected to be signed by the end of 2007.
- PIC/S and WHO's Department of Immunization, Vaccines and Biologicals (IVB) are in the process of negotiating a cooperation agreement covering the exchange of information, training, and harmonization of audit tools.

PIC/S SEMINAR: SINGAPORE, 20 – 22 NOVEMBER 2007

A training Seminar for inspectors on the subject of “Inspection of Manufacturers of Solid Dosage Forms” was held in Singapore on 20 – 22 September 2007. The Seminar was organized by Singapore's Health Science Authority (HSA) and was the first time that a PIC/S Seminar had been held in Asia.

The Seminar was attended by 130 participants from 45 different regulatory agencies, including 13 agencies from the Asia region. Speakers at the Seminar were mainly from PIC/S participating authorities, but also from academia, as well as one speaker from industry (Gordon Farquharson who represented ISPE).

The Seminar focused on the following topics in the field of GMP inspection of manufacturers of solid dosage forms:

Challenges and issues (e.g., the interface between GMP inspection and drug evaluation).
Technology advances and new initiatives (e.g., PAT and process understanding).
Production and quality control (e.g., control of starting materials, in-process, and packaging controls, cleaning validation for multi-product manufacturing facilities).
Environmental control and segregation requirements (e.g., air cleanliness classification for manufacturing facilities).

An entire day was dedicated to parallel workshops. One workshop consisted of case studies on deficiencies and their classification during GMP inspection. Two other workshops were dedicated to the inspection of the manufacturing facilities (air cleanliness, microbial, and environmental monitoring) and the need for dedicated equipment or segregated facilities for highly active and/or sensitizing agents.

The presentations made at the Seminar are available on CD-ROM ⁵.

PIC/S MEETING WITH ASEAN REGULATORY AUTHORITIES: SINGAPORE, 22 NOVEMBER 2007

A meeting between PIC/S and ASEAN regulatory authorities took place in Singapore on 22 November 2007 following the PIC/S Seminar. Representatives from the regulatory authorities of Brunei Darussalam, Indonesia, Malaysia, Philippines, Singapore, Thailand, and Vietnam attended the meeting.

This was the first meeting held between PIC/S and ASEAN regulatory authorities. The meeting enabled both PIC/S and ASEAN to present their respective organization and to explore possible ways of cooperation on GMP training and GMP Guides and guidance documents. For PIC/S, it was of particular interest to note that ASEAN countries are in the process of harmonizing their GMP inspection systems through negotiation of an MRA between all ASEAN regulatory authorities taking PIC/S and the PIC/S GMP Guide as a reference. A draft of this MRA is expected by the end of 2007.

PIC/S and ASEAN regulatory authorities agreed to cooperate in the following fields:

Training of inspectors (e.g., joint visits or coached inspections).
Preparation of application for PIC/S membership.
Sharing of information (e.g., Rapid Alerts, import for export-only products).
Sharing of knowledge on inspection of herbal medicines.

REFERENCES:

Regulatory Review Article Archives. 1 August 2005. ISPE Web site ( www.ispe.org ).
The 31 regulatory authorities that are members of PIC/S (as at 1 December 2007) 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, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
PIC/S Press Release, dated 3.12.07, available as PDF document at: ( http://www.picscheme.org/index.php?p=news )
“Expert Circles” are described within the “Role & Functions” page of the PIC/S Web site ( www.picscheme.org/index.php?p=role ).
The proceedings of PIC/S Seminars are available for purchase from the PIC/S Secretariat, 14, rue du Roveray, CH-1207 Geneva, Switzeraland. E-mail: info@picscheme.org.