Appointment of Bob Tribe as PIC/S chairman

On 13 September 1999, Mr Bob Tribe, the TGA's Chief GMP Auditor, was elected Chairman of PIC/S (Pharmaceutical Inspection Cooperation Scheme) for a period of 2 years.

A total of 21 Health Agencies from 20 countries*, mainly from Europe but also including Canada and Australia, are members of PIC/S.

The main functions of PIC/S are:

• to exchange information and experience on GMP (Good Manufacturing Practice) for medicines, including exchange of GMP inspection reports and GMP certificates;
• to facilitate the training of GMP inspectors by means of regular seminars and a joint inspection training program, with a view to harmonising GMP inspection activities;
• to arrange Expert Circle meetings to discuss specific areas of GMP involving the inspection of manufacturers of medical gases, blood banks, hospital pharmacy and other specialised areas;
• to develop guidance documents on different aspects of GMP, eg. validation, sterility testing, isolator technology and Quality Systems for GMP Inspectorates;
• to facilitate networking and confidence building; and
• to facilitate international harmonisation on GMP.

Countries that have expressed interest in joining PIC/S include Singapore, Taiwan, Malaysia, Estonia, Latvia, South Africa and the USA.

Bob was also elected Chairman of the PIC (Pharmaceutical Inspection Convention) at the same time. PIC is a formal treaty between member countries and has similar functions to PIC/S (but PIC/S is a less formal arrangement between Agencies). There are 18 countries that are members of PIC, with Australia the only member outside Europe. Because of a conflict between the PIC treaty and EU law, PIC will eventually be disbanded and replaced by PIC/S once Austria, Germany and Italy join PIC/S. This is expected to happen next year.

Bob joined the Department in 1971 as a GMP inspector, having worked previously as a Quality Assurance Manager for a multinational pharmaceutical company. He has been Chief GMP Auditor since 1980 and is responsible for the management of TGA's manufacturer audit and licensing program for medicines and medical devices.

*Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Hungary, Iceland, Ireland, Liechtenstein, Netherlands, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, Switzerland (2 Agencies), United Kingdom.

Avoiding delays when making changes to manufacturer's information in provisional records of registration for medicines

Over the last twelve months there has been a steady increase in the number of provisional records of registration being returned to the Australian Register of Therapeutic Goods (ARTG) with a request for amendment. These requests involve amendments to the street address or the postal address of a particular site of manufacturing or changes in manufacturer's names. The changes frequently lead to delays in the registration of products while the matters are clarified with the Good Manufacturing Practice Audit and Licensing Section (GMPALS) and the Drug Safety and Evaluation Branch (DSEB).

All manufacturers performing steps in the manufacture of registrable and listable products must hold current GMP evidence which contains the address of the manufacturer and includes the steps of manufacture that are permitted to be undertaken at the stated site.

To prevent delays in the finalisation of the product registration, where a sponsor holds a new certificate or what they consider to be an updated certificate, they should submit the certificate to GMPALS before the product evaluation process is completed. This will allow time for the updating of the internal TGA records such that the changes would be reflected in the provisional record when first created.

If a sponsor wants to alter the addresses in any way they must:

• be able to provide a new Certificate of Pharmaceutical Product (CPP) from the relevant country's Department of Health or a new licence which supersedes the current one held in GMPALS; and
• attach the documentation to the completed Annex B form (available electronically from GMPALS or in the current edition of Standard of Overseas Manufacturers); and
• submit directly to GMPALS to the attention of either Ms Vicki Partridge (02) 6232 8627 or Ms Chris Tait (02) 6232 8012; and
• submit a copy of the documentation to the ARTG when returning the provisional record with the request for amendment to alert the ARTG staff of the discrepancy and to inform them that the relevant documentation has been submitted through the proper channels.

Once processed by GMPALS this would allow amendment of the Provisional Record of Registration.

If no supporting evidence can be produced to GMPALS then the TGA records cannot be altered and the manufacturer's details must remain as they are in TGA's record and on the Provisional Record of Registration.

TGA Approved Terminology for Medicines

Copies of the 1999 edition of the TGA Approved Terminology for Medicines <http://www.tga.gov.au/docs/html/aan.htm> CD ROM are selling well and it has proved to be very popular with both sponsors and manufacturers.

The CD ROM assists sponsors in completing application forms for entry of medicines or disinfectants in the Australian Register of Therapeutic Goods. It also assists TGA officers to process applications received as both parties are using the same Australian approved terminology.

Please contact the TGA Publications Office on 1800 020 653 for further information.

University of Technology Sydney visit to TGA

In late September 1999, forty students from the University of Technology, Sydney visited the TGA. The medical laboratory science students, accompanied by their lecturer, Associate Professor Loraine Holley, attended talks and demonstrations given by officers of the TGA medical devices program.

The presenters gave an overview of the different types of medical devices currently on the market in Australia and the way in which they are regulated. Overviews on risk analysis, the Incident Report Investigation Scheme and a summary of the proposed new framework for medical devices were also provided.

In the afternoon, the students were taken on a tour of the TGA Laboratories where they were able to have a "hands on" look at the work of the laboratories and an opportunity to take part in practical demonstrations.

The students gained valuable insights into the work of the TGA.