Licensing of medicinal gas manufacturers

Schedule 7 (therapeutic goods exempt from the operation of Part 4 of the Therapeutic Goods Act 1989 unless supplied as pharmaceutical benefits) has been amended by an amendment to the Therapeutic Goods Regulations dated 15 July 1998. The following additional exemption has been included:

"Medicinal oxygen cylinders that have been decant filled, transfilled or cascade filled by an organisation for use on patients under the direct care of that organisation". Manufacturers that fill medicinal gases and are not exempt from licensing by the above inclusion in Schedule 7 are advised to contact the GMP Audit and Licensing Section, Conformity assessment Branch by telephone: (02) 6232 8629 or fax: (02) 6232 6426, as soon as possible to obtain the prescribed form to apply for a manufacturing licence. The penalties for manufacturing therapeutic goods without a licence issued by the TGA are severe.

New address for the NRL

The National Serology Reference Laboratory, Australia (NRL) has been relocated to its new host institution, St Vincent's Institute of Medical Research (SVIMR), as of 13 July 1998. The NRL's new address and contact details are:

4th Floor, Healy Wing
41 Victoria Parade
FITZROY VIC 3065
Ph: 61 3 9418 1111
Fax: 61 3 9418 1155

The NRL supports the Therapeutic Goods Administration (TGA) in the evaluation of HIV and HCV diagnostic tests prior to inclusion in the Australian Register of Therapeutic Goods (ARTG). The NRL also monitors post market performance of registered kits in Australia and co-ordinates a national laboratory quality assurance program.

Pharmaceutical labelling

What all contract manufacturers and sponsors should know about label verification

Contract manufacturers of pharmaceutical products are reminded of their responsibility to ensure that any product labels supplied to them by sponsors for use in manufacture are appropriately verified.

The Code of GMP requires labels and pre printed packaging materials to include an optical barcode (or equivalent means of verification) to minimise the problem of label error or mix up. The optical barcode often used for this purpose is the "Pharmacode" and this allows scanning, either off line or on line, to verify each label. The "Pharmacode" should not be confused with the APN bar code which only identifies the product and not the current revision of the label text.

Manufacturers were advised in the February 1995 issue of the GMP Newsletter of their responsibility to comply with this requirement of the code of GMP. However, it is evident that some sponsors are still providing unverified labels to their contract manufacturers and this practice will no longer be accepted by the GMP Audit and Licensing Section.

Sponsors are advised to ensure that any labels supplied to contract manufacturers have either been verified or contain an optical barcode for label verification by the manufacturer.

Revised breast implant booklet released

A revised version of the Breast Implant Information Booklet, which provides an up-to-date guide to enable women to make careful and informed decisions about whether to undergo breast implant surgery, has just been released by the TGA.

The Breast Implant Information Booklet will provide women with a balanced view of the risks and benefits of breast implants. The booklet, first published in 1995, clarifies many of the issues raised at the outset of the silicone gel controversy.

Silicone gel-filled breast implants were developed in the early 1960s to improve the options for women requiring mastectomies or correction of congenital deformities. In the early 1990s, there was growing concern about the safety of the implants resulting from anecdotal reports of leakage of silicone gel and its spread through the body. At the time, rigorous and systemic studies had not been conducted to establish the safety of these implants.

A review of recent scientific literature has now established that there is no convincing evidence that silicone gel-filled breast implants cause cancer or any classic connective tissue disorder.

However there is no doubt that, as the implants age, they can cause local complications which may result in a need for replacement.

The first edition of the Breast Implant Information Booklet was published in 1995 and a pamphlet - Information on Silicone Gel-filled Breast Implants - was released in 1993. The current booklet, which will be free-of-charge, explains in plain English the type, life expectancy, and the risks and benefits of breast implants. It also gives information on breast implant surgery including any complications.

The Breast Implant Information Booklet <http://www.tga.gov.au/docs/html/breasti.htm> will be distributed widely by the TGA through plastic surgeons, Women's Health Centres and Cancer Societies. It is also available on this Internet site.

Training course on sterilisation standards

The Therapeutic Goods Administration (TGA) in conjunction with the UK Medical Devices Agency (MDA) will be conducting a four day course on current sterilisation standards for medical devices from 6 to 9 October. The course will be aimed at those personnel involved in sterilisation of medical devices. as well as quality systems auditors involved in the auditing of sterile medical device manufacturers. Attendance at the course will build on existing skills, and develop a knowledge of application and sterilisation processes.

The course will focus on the current European sterilisation standards for medical devices which have been published or are in preparation, including EN 550, EN 552, EN 554, EN 556, EN 1174-1, EN ISO 14160 and international equivalents. These include sterilisation by irradiation, ethylene oxide gas, dry heat and steam, and liquid chemicals.

The course format will include lectures, discussion groups and case studies together with individual and syndicate group exercises.

Each attendee will receive a comprehensive set of lecture notes, training material and a set of the relevant standards. A certificate will be issued to those who successfully complete the course.

Cost: $1800 includes 4 days registration, lunches, morning/afternoon teas and course materials.