TGAL'S peripatetic microbiologist

Vivienne Christ and Terry Slater, National Manager TGA

Chief Microbiologist, Ms Vivienne Christ was invited to present an overview of the TGA's approach to disinfectant and sterilant regulation during a panel discussion at a symposium on sporicides at the Association of Analytical Chemists (AOAC) annual meeting held in San Diego, California, September 1997. The forum provided an excellent opportunity for open discussion on this topical issue between industry, US EPAand FDA, and international representatives. Technical presentations on current developments and future directions for sporicidal testing preceded the panel discussion. Since the TGA has adopted the AOAC Sporicidal test as our preferred test for registration of high-level disinfectants and sterilants, it is essential that we be aware of any proposed changes to test methodology. This enables us to assist Australian industry and contract testing laboratories and facilitates TGA's participation in international collaborative studies.

Next was a visit to Stockholm, Sweden where Ms Christ was the official delegate of Standards Australia at the annual meeting of the International Standards Organization, Technical Committee 198 (ISO/TC 198) - Sterilization of healthcare products. Australia is a full participating member of this committee. This is important in view of the role of ISO and EN standards for meeting the essential requirements under the European Medical Device Directive (MDD), and their adoption by pharmaceutical manufacturers, where relevant. At the meeting, a number of standards were finalised for voting as final ISO standards, and progress was made on drafts of others. Work also commenced on new standards for labelling and reprocessing of reusable medical devices, and for the performance of washer-disinfectors, which are relevant to the TGA and the Australian industry.

The President of the International Association for Pharmaceutical Science and Technology (PDA), Dr Edmund M. Fry recently extended an invitation to Ms Christ to present the Korczynski Lecture at the PDA 1997 Annual Meeting, Courses and Exhibition, "Meeting the Challenges of Change". This invitation was in recognition of Ms Christ and the work of the Microbiology Section, particularly in relation to the harmonisation of the sterility test. The meeting was held in Philadelphia, from November 10-12, 1997. The lecture and the associated travel grant is named in honour of PDA past president, Michael S. Korczynski, who was instrumental in advancing PDA international activities. Ms Christ has been asked to present TGA's and her own views on global harmonisation of a number of microbiological issues, which will include the sterility test, preservative efficacy testing, and microbial limits for non-sterile products.

Detection methods for glycols following separation by thin layer chromatography

Following the 1996 outbreak of diethylene glycol (DEG) poisonings in Haiti where many children died, the WHO and the FDA set a 0.1% DEG limit for pharmaceutical raw materials and glycerin based elixirs. A TLC method for separation of glycols was developed by the FDA but WHO also required a cheap detection method that could be easily performed in the field. In response, Robert Prestridge and Kirsten Sharp from the Chemistry Section TGAL have developed a quick, robust and inexpensive method of detecting glycols in the Standard TLC test.

The method relies on the oxidation of glycols by potassium permanganate. It satisfies sensitivity requirements since it allows detection of 1µg or less of glycols equivalent to 0.01%. The work is soon to be published on behalf of WHO in the Journal of the Association of Official Analytical Chemists in collaboration with Dr Allen S. Kenyon's laboratory, Division of Drug Analysis, FDA.

Changes to structure of TGA Laboratories Branch

Dr Gary Grohmann has been appointed to head the Immunobiology section and took up his position in November. Gary has over 20 years experience in medical and environmental virology with a strong interest in public health virology, molecular diagnostics, viral immunology, prion diseases and viral vaccines and safety. After his university studies (BSc hons., UNSW and PhD, Sydney) he spent 14 years in clinical hospital virology, research for two years at the Center for Disease Control, Atlanta, Georgia, USA and four years at Sydney Water. He has spent the last 18 months as a private consultant in virology and holds adjunct academic appointments in the Department of Veterinary Anatomy and Pathology, University of Sydney and in the School of Microbiology and Immunology, University of NSW.

Following the retirement of Mr Russell Beckett and Mrs Jan Finn, the Animal Services section ceased to exist as a separate unit and its functions have been incorporated into the framework of the Immunobiology section. The Laboratory workshop has been relocated and refitted and is now administered by the Biomaterials and Engineering section.

Dr Clive Morris has been appointed as section head of Molecular Biology. Clive came to the TGA in 1994 from the then National Food Authority (NFA, now Australia and New Zealand Food Authority). After graduating from the University of Queensland (BSc Hons, PhD), Clive spent several years doing medical research in both the UK and Australia before joining the NFA in late 1992. His scientific expertise lies in the areas of protein chemistry, molecular biology and cell biology.

The TGA Laboratories Executive Unit has been restructured. Dr Margaret Smith is the contact for laboratory matters and Dr Garry Hopkins has been appointed to liaise with outside organisations.

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Quality of vaccines workshop

Workshop on the Role of National Control Authorities
in Ensuring the Quality of Vaccines
25-29 August 1997 Manila, Philippines

A Workshop on the Role of National Control Authorities in Ensuring the Quality of Vaccines was held at the World Health Organization Western Pacific Regional Office, Manila, Philippines, on 25 - 29 August 1997. The NCAs of Australia, Japan, Korea, China, Vietnam, Philippines, Singapore, Malaysia participated, together with Dr Julie Milstein from the Global Programme for Vaccines & Immunisation, WHO, Geneva, and WHO Western Pacific Regional Office staff who provided the Secretariat. Observers from the International Vaccines Institute, the United Nations Children's Fund (UNICEF), the Philippine-Australia National Drug Policy Co-operation Project, and the Department of Health, Philippines also participated.

The objectives of the workshop were to review the operation, responsibilities, structure and legislative basis of National Control Authorities (NCAs) with respect to vaccine quality, to discuss the relationship between NCAs and manufacturers, to define the responsibility of the National Control Laboratory and its relationship with the NCA, and to establish a system for information exchange and collaboration between NCAs in the Region.

Chris Rolls (TGAL) and Dr. Greg Smith (GMP Audit and Licensing Section) were involved in preparing the workshop content and presenting and facilitating many of the sessions. Dr. Smith, as the rapporteur, prepared the report for ratification by the WHO Secretariat.

Workshop outcomes included recognition of TGA's excellence in this field, the facilitation of communications between participants, and the identification of further assistance that TGA can provide to neighbouring countries through WHO. TGA will continue to provide training for countries with well developed regulatory systems for pharmaceuticals who need assistance to develop expertise in the regulation of vaccines. In addition TGA, in response to requests from WHO, may provide more intensive assistance to countries with less developed regulatory systems, including review of the operation, responsibilities, structure, and legislative basis of their National Control Authority. WHO will co-ordinate further activities arising from the workshop.

European Commission Decision 97/534/EC: Transmissible Sprongiform Encephalopathy Risk Material of Aminal Origin used in Manufacture of Products Exported to the EU

As of 1 January 1998, companies exporting medical, pharmaceutical or cosmetic products to the European Community may be required to supply a declaration that the products (or their starting materials or intermediate products) do not contain and are not derived from animal materials at risk of transmitting spongiform encephalopathies. Such declarations will have to be issued by a Competent Authority in the country of production, but will be required only upon request from the importing country. The specific risk materials defined in the Commission Decision 97/534/EC are the skull, including the brain and eyes, tonsils and spinal cord of bovine, ovine and caprine animals and the spleen of ovine and caprine animals.

TGA has discussed this matter with the Australian Quarantine Inspection Service (AQIS) and derogation from the above EC Decision is being sought, based on Australia's status as a country free from transmissible spongiform encephalopathies affecting animals. A decision is expected from the European Commission by the end of December. At that time there will be a further meeting of TGAL and AQIS to determine procedures for companies who may be requested by European authorities to supply a declaration in relation to the above Decision.

Australian influenza vaccine for the 1998 winter

The composition of Australian Influenza Vaccine for the 1998 winter season was agreed at the meeting of the Australian Influenza Vaccine Committee (AIVC) held on 10 October 1997. Influenza surveillance data was reviewed for New Zealand (Dr David Featherstone), South Africa (Professor Barry Schoub and Dr Terry Besselaar) and Australia (Mrs Margaret Curran). Mr Alan Hampson presented a detailed analysis of WHO's surveillance data. As a result, changes will be made to the A components of the formulation of last year's vaccine.

Influenza vaccines for the 1998 season will contain the following:

.A (H1N1):	an A/Bayern/7/95 (H1N1) -Like strain -NIB 39, a reassortant of A/Johannesburg/82/96 is suitable
.A (H3N2):	an A/Sydney/5/97 (H3N2) -Like strain -Reassortants of A/Sydney/5/97 and its equivalent A/Auckland/20/97 are suitable
.B:	a B/Beijing/184/93 -Like strain -B/Harbin/7/94 is suitable