PIC/S* seminar and committee meeting

In October 2000, Mr Bob Tribe and Mr Alan Duff, of the Conformity Assessment Branch of the TGA, attended the annual PIC/S training Seminar in Colmar, France, on the Inspection of Manufacturers of Biotechnology Products.

The Seminar, which concentrated on technical and regulatory aspects of biotechnology products as well as on the inspection of biotechnology manufacturing sites, included a visit to a local insulin-producing manufacturer and to the European Directorate for the Quality of Medicines (EDQM/European Pharmacopoeia). The Seminar resulted in the establishment of a PIC/S Working Group whose main task will be to draft an Aide-Memoire on the inspection of biotechnology plants and to establish a scope and work plan for an Expert Circle on Biotechnology that is to be convened later in 2001.

The opportunity was taken at the end of the Seminar for the GMP regulators of Australia, Canada, New Zealand, Switzerland and the USA to meet and discuss the possibility of having a harmonised batch certificate for the various Mutual Recognition Agreements (MRAs) between these countries.

Prior to the Seminar, Mr Tribe chaired a meeting of the PIC/S Committee of Officials, which discussed, amongst other things, applications for membership of PIC/S, cooperation with EMEA, training of GMP inspectors and development of PIC/S guidance documents.

More information on the Seminar and the meeting of the PIC/S Committee of Officials can be found in a Press Release on the Publications page of the PIC/S website <http://www.picscheme.org>.

* Pharmaceutical Inspection Cooperation Scheme

Signing of a cooperative arrangement with FDA (USA) covering pharmaceutical GMP

On 11 October 2000, the TGA signed a Cooperative Arrangement with the US Food and Drug Administration (FDA), regarding the exchange of information on current Good Manufacturing Practice (GMP) inspections of human pharmaceutical manufacturing facilities. The Australian Minister for Health and Aged Care, Dr Michael Wooldridge, signed the agreement on behalf of the TGA and Dr Jane Henney, Commissioner of Foods and Drugs, signed for the FDA.

Under this agreement the FDA and the TGA express their intent to:

• Provide copies of pharmaceutical establishment inspection reports (confidential information purged) and product sample results to one another, upon request, within certain specified timeframes
• Notify one another when one authority plans to conduct inspections in the other authority's territory and be receptive to permitting joint inspections for the purpose of promoting better understanding of one another's inspectional programs and techniques.
• Provide other GMP-related information such as recall information, adverse product trends, health hazard evaluations and alert system information.
• Exchange appropriate information about manufacturers when shortage situations occur involving medically necessary human pharmaceuticals.

The information in the inspection reports will allow the FDA and the TGA to make their own decisions concerning the compliance of manufacturers and appropriate follow up. Each agency may carry out its own inspections in the other's territory if it deems necessary.

The agreement applies to GMP inspections of pharmaceutical facilities where the inspections have been conducted using the current FDA GMP requirements for drugs or the current TGA GMP Code for medicinal products.

Full text of the Cooperative Arrangement: Cooperative arrangement between the FDA (USA) and the TGA (Australia).

TGA initiative leads to finalisation of an internationally harmonised GMP for active pharmaceutical ingredients (APIs)

In September 1996, the TGA convened an international conference involving government regulators and key industry representatives to discuss the need for an internationally harmonised GMP Guide for Active Pharmaceutical Ingredients (APIs). The two day Conference, which was opened by the TGA National Manager, Mr Terry Slater, concluded with a consensus for the Pharmaceutical Inspection Convention (PIC) to commence work on the preparation of a draft GMP Guide.

The TGA prepared the first draft of a GMP Guide that was provided to PIC for further development. After extensive work by PIC, it was decided to refer the PIC draft document to the International Conference on Harmonisation (ICH) so that industry could become involved in finalising the document.

An ICH Expert Working Group was formed and, under the chairmanship of Dr Gordon Munro of the Medicines Control Agency (MCA), UK, refined the document further after seeking public comment internationally. Mr Bob Tribe (TGA) was the Australian representative on this Expert Working Group, with Mr Alan Duff (TGA) deputising for Mr Tribe at several meetings.

At the 5th International Conference on Harmonisation (ICH5), held in San Diego on 9-11 November 2000, the document was finalised. It was agreed that the three ICH regions (the US, Europe and Japan) would adopt the document into legislation by 1 April 2001. Many other non-ICH countries, including Australia, are expected to also adopt the ICH GMP Guide for APIs into legislation in the near future.