A constructive interchange

Information from the chemical detective work of the TGA Laboratories has resulted in a constructive lesson for manufacturers and sponsors using soft gelatin capsules. Using the TGA's information, a group of companies has been able to improve their process control. The story of paraben (methyl, ethyl or propyl hydroxybenzoate) in soft gelatin capsules should alert all involved in the supply of therapeutic goods that control has to cover supplies as well as processes on site and despatch conditions.

A TGA survey of 13 products in soft gelatin capsules labelled as "preservative free" found 11 products with paraben preservative in the capsule shell. Products were randomly selected from retail outlets and tested at the TGA Laboratories. The TGA passed this information to the companies concerned who investigated internally and took appropriate action.

The causes of the presence of paraben varied between sponsors but each problem arose from a lack of attention to all steps in the process. This highlights the need to be certain of the control measures of suppliers. A buyer must clearly specify requirements and know how well, for example, suppliers check for cross contamination between batches with different formulations prepared in the same equipment.

Consumers expect, and the law supports this expectation, that by consuming products labelled "preservative free" they will not be taking any preservative at all. Further, certain substances like paraben must also be declared on the label if present.

A first for the TGA in international microbiological standards

The TGA is now directly involved in developing international standards for the sterilisation of health care products. For the first time, as a result of the efforts of Standards Australia, a representative from Australia attended the specialist annual meeting on these standards as a full participating member. The meeting was held last October in Arlington, USA. Ms Vivienne Christ, the TGA's Head of Microbiology, participated in the process established under the auspices of the International Standards Organisation (ISO).

Ms Christ said that this was significant for both the TGA and industry because it would maintain Australia's credibility in this field and ensure Australia had appropriate input into standards used for GMP audit and registration or listing of therapeutic goods. Further, the ISO connection is critical for Australia's involvement in some European Standards. Many of the standards will be jointly formulated by the ISO and the European Committee for Standardization under article 5.1 of the Vienna Agreement.

For the past two years, the TGA has been involved in the work of the ISO Technical Committee 198 - Sterilization of health care products - by providing comment on draft standards. The elevated status will now enable Australia to be pro-active in a large range of standards development for sterilization processes such as those necessary for medical devices, microbiological methods, biological and chemical indicators and packaging and terminology.

Changes at the Laboratories

After 33 years in the National Biological Standards Laboratory (NBSL) / TGA Laboratories, John Howard has retired. The TGA farewelled John in March, lamenting the loss of his considerable expertise and experience, particularly in chemistry. John's role in supporting Laboratories management has been taken up by Dr Helen Cameron from the Australia New Zealand Food Authority, who has worked with the TGA previously as a toxicologist and briefly last year as Business Manager.

Two other long standing staff members have left, both from Immunobiology - Sandra Paul and Zlata Wallner - and we wish them well in their retirement.

Confidence in herbal authenticity

The TGA Laboratories are devising ways of determining the authenticity of herbal medicines. Despite the complexity of the chemical mixture derived from the herbal plant material in the preparation of these medicines, chemical fingerprints of genuine material can be obtained.

The TGA's high pressure liquid chromatography methods produce graphical results for easy identification of the presence of undesirable chemicals in a product. If a manufacturer were to use a substitute herb, the pattern of peaks would look markedly different.

Failures of a herbal product to contain the appropriate active material in the appropriate amounts, and without toxic contaminants, can occur through various means, not necessarily by deliberate action. There are potential problems with the quality of herbal medicines arising from the choice of plant material, methods of harvesting and processing and seasonal variation.

The TGA is encouraging wider discussion on appropriate regulatory mechanisms for herbal medicines in appreciation of their differences from synthetically produced medicines. In consulting with academics and specialists in Australia and overseas, the TGA believes that both herbal medicine manufacturers and consumers will benefit. At a recent seminar for all of the TGA sections involved in the regulation of herbals, the issues of auditing herbal manufacturers and the establishment of reference material were two important topics as well as the comparison between the regulatory approaches of different countries.

Microbiology in future device regulation

The TGA's Principal Microbiologist, Ms Shelley Tang, was a key participant in the popular seminar Future device regulation in Australia - the European approach held in Sydney in March 1997. The TGA organised this seminar with the Medical Industry Association of Australia to help industry to understand the proposed regulatory system for devices under the European Mutual Recognition Agreement.

Ms Tang brought to the seminar the benefits of her recent experiences in the United Kingdom and the United States. Having taken a pertinent four day training course in Manchester UK, she discussed the place of sterilisation standards in the regulation of sterile device manufacture under the European system of device regulation.

The training course was organised by the Medical Devices Agency of the UK on behalf of the European Union. It was intended for quality systems auditors required to operate under the European system, but has been opened to outsiders and a particular invitation was extended to Australia. The course helps Notified Bodies in the European system to interpret standards recently published, or in preparation, for device sterilisation practices.

Ms Tang attended the Annual Meeting of the US Parenteral Drug Association in Philadelphia and discussed disinfectant regulation and contact lens solutions with the FDA Office of Device Evaluation in Washington DC.