TGA Office of Laboratories and Scientific Services

About the TGA Office of Laboratories and Scientific Services

Through the Therapeutic Goods Administration (TGA), the Commonwealth regulates the quality, safety and efficacy of therapeutic goods. The main roles of the Office of Laboratories and Scientific Services (OLSS) are pre-market assessment support in technical areas and post market monitoring to ensure that products are of acceptable quality as defined by official standards or specifications as agreed with the manufacturer.

The Laboratories

• undertake pre-market assessment of chemistry, quality control and manufacturing data for biologicals, vaccines, medical devices and batch release review/testing
• undertake post-market testing, quality assessment and test procedure development in microbiology, virology, immunobiology, molecular biology, antibiotics, medical devices and pharmaceutical chemistry. This includes relevant method development and validation activities to maintain the best possible testing methods for medical devices, drugs and biologicals.
• provide administrative and scientific advice to government, industries and consumers and work closely with other international regulatory authorities
• provide training in testing techniques and other relevant regulatory functions
• provide specialist support to TGA audit teams.

Organisation

The Office of Laboratories and Scientific Services is located in the TGA's Symonston complex. The complex includes well-designed laboratories with numerous features to protect the environment and laboratory workers from accidental exposure to chemicals used in the analysis and testing of therapeutic goods. The laboratories were first occupied in the spring of 1992.

OLSS has around 100 staff consisting of scientists, engineers, technicians and support staff. Approximately one-half of the staff are graduates in science, with over one-third of these holding doctorates. Most of the staff work in laboratory streams based on scientific discipline and product type. In addition there is a small management group comprising the Director, Scientific Advisors, Quality System Manager, Laboratory Information Management System Manager, and their support staff.

The science staff are qualified in biochemistry, chemistry (mainly organic and analytical), engineering, materials science, physics, zoology, botany, microbiology, molecular biology and virology. They have developed expertise to apply their basic knowledge to the testing and evaluation of therapeutic goods. Development work contributes to monograph standards and reports are published in scientific journals and in the TGA Laboratory Information Bulletin <http://www.tga.gov.au/docs/html/lib/libindex.htm> which is circulated widely in Australia and overseas.

Product testing

Samples for the testing program are obtained from manufacturers, wholesalers, chemists, hospitals or retail outlets. TGAL tests, on average, around 1500 samples of products annually and problems with quality are noted. The failure rate does not reflect the general level of compliance with standards demonstrated by the range of products supplied in Australia, as the sampling program is targeted according to considerations such as:

• the variability inherent in the manufacturing and quality control procedures;
• advice from the GMP auditors following audits of individual manufacturers to determine compliance with the Code of Good Manufacturing Practice;
• investigation of complaints from consumers and practitioners regarding product performance;
• analysis of products prior to inclusion in the Schedule of Pharmaceutical Benefits;
• conduct of product type surveys to follow up literature reports of problems in other countries;
• repeat testing of products with a history of poor compliance with relevant standards; and
• development and/or availability of improved methods of analysis.

Some products, such as vaccines, are tested frequently as a subpotent batch can seriously affect children's immunity to infection. The Laboratories have developed special expertise in identifying counterfeit medicines and in assessing the quality assurance of herbal products and traditional complementary medicines.

To carry out its testing programs effectively, OLSS must use state of the art methodology. Consequently, there is an active program of developmental research into new and improved methods and the training of staff in new technology. Particular effort is made in developing test procedures to replace those which use animals. As a result of the development of improved chemical testing and the use of cell culture techniques, TGAL has been able to drastically reduce the number of animals used.

As it is essential that OLSS can assure the integrity of its results, systems are in place to track samples and ensure their appropriate testing. Each piece of equipment used must be operating correctly and is therefore maintained and calibrated regularly. As a further check, the quality system is audited by the National Association of Testing Authorities (NATA), an independent body, and each section of OLSS is required to maintain NATA accreditation.

Pre-market assessment

A significant role of the Office of Laboratories and Scientific Services is assisting with the assessment of the adequacy of data provided by the manufacturer to establish the quality, safety and efficacy of therapeutic goods before they are marketed. The information is supplied in applications for registration of new drugs and devices for the Australian market. The Laboratories work with other branches and the Regulators in the evaluation of manufacturing and quality control aspects of prescription medicines, over-the-counter medicines, complementary medicines and medical devices.

OLSS is responsible for evaluating the chemistry, quality control and manufacturing data submitted by the manufacturer in support of:

• vaccines
• cytokines
• blood products
• hormones and enzymes
• other biological medicines
• monoclonal antibodies

In addition, staff of OLSS review the microbiological aspects of the manufacture of injectable products and other sterile therapeutic goods and viral, endotoxin and cytotoxin safety of a wide range of drugs and devices. Staff of the Laboratories issue Certificates of Release for batches of vaccine products, based on assessment of a summary of company protocols for manufacture and testing procedures. These certificates support export certification issued by the TGA under the World Health Organization (WHO) scheme for certification of pharmaceuticals involved in international trade. Batch release of other biological products is based on testing results.

Laboratory Information Management System

All laboratory testing is recorded and monitored by a Laboratory Information Management System (LIMS). The system provides an integrated approach to sample management, from selection of products for testing to the reporting stage. It therefore underpins the Laboratory quality system and makes a significant contribution towards meeting the requirements of NATA accreditation. The LIMS is also important in providing information rapidly on all aspects of testing so that any questions raised in Parliament or by interested individuals and groups may be answered quickly and accurately.

International activities

As an integral part of the regulatory process, OLSS staff are involved in the development of standards for therapeutic goods, at both the national and international levels. These may take the form of guidelines for industry, Australian Standards, ISO standards or input to pharmacopoeial committees. Two senior officers are corresponding members of Committees of the British Pharmacopoeia. TGAL staff also have observer status on several expert committees of the European Pharmacopoeia.

OLSS staff also provide scientific advice and specialised training in laboratory techniques to staff from other government bodies.

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