Laboratories Branch

13 April 2011

The Therapeutic Goods Administration (TGA) carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard.

Key to the provision of this service is the Laboratories Branch whose main roles are to:

  • Undertake laboratory testing and quality assessment for therapeutic goods in accordance with the assessed risk of the products. This includes relevant method development and validation activities to maintain currency in testing methods for medicines, vaccines, biological products and medical devices;
  • Review manufacturing and testing data from companies to check that individual batches of vaccines and selected biological products comply with approved specifications prior to the batches being released to the market;
  • Provide scientific expertise to assess technical data for the registration and inclusion of therapeutic goods on the Australian Register of Therapeutic Goods (ARTG);
  • Provide administrative and scientific advice to the TGA, expert committees, government, industries and consumers;
  • Provide technical expertise for the development and maintenance of national and International standards;
  • Provide training in testing techniques and other relevant regulatory functions; and
  • Maintain appropriate international cooperation.

Organisation

The Laboratories Branch is located in the TGA's Symonston complex in the Australian Capital Territory. The Office has around 90 staff consisting of scientists, engineers, technicians and support staff. Approximately 70% of these are science graduates, of which around 30% hold doctorates.

The science staff are qualified in biochemistry, chemistry (mainly organic and analytical), engineering, materials science, pharmacology, physics, zoology, botany, microbiology, molecular biology and virology. They have developed expertise to apply their knowledge to the regulation of therapeutic goods, which includes laboratory testing, evaluation and assessment of technical data and development of standards.

Most of the staff work in laboratory streams based on scientific discipline and product type. The Laboratories Branch sections include:

  • Biochemistry
  • Biomaterials and Engineering
  • Chemistry
  • Immunology
  • Microbiology

In addition there is a small management group comprising the Branch Head, Scientific Operations Advisor, Quality System Manager, Laboratory Information Management System Manager, and their support staff.

The operational arrangement within the TGA is for the Laboratories Branch to:

  1. Provide support to the Monitoring and Compliance Division in laboratory testing investigation and review of marketed therapeutic goods.
  2. Provide support to the Market Authorisation Division in the evaluation and assessment of technical data in applications to include therapeutic goods on the ARTG.
  3. Provide scientific advice to the TGA as a whole and its stakeholders.

The well-designed laboratories include 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.

See Laboratories Branch activities for more information.

Contract services

The Laboratories Branch provides testing and training services on a contractual basis to other national regulatory authorities, international organisations and Australian government departments.

These arrangements are only agreed where such work is in line with the TGA's overall aims and objectives and where it does not involve the TGA in any conflict of interest relating to its role in the regulation of therapeutic goods.

The training offered to other national regulatory authorities is mainly in testing methodology, quality assurance and laboratory management.

Further information

Enquiries concerning laboratory testing, training programs and quotations are welcome. Please contact:

Branch Head, Laboratories Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia

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