The TGA Laboratories perform a range of activities to ensure therapeutic goods are of an acceptable standard.
These activities include:
- laboratory testing of therapeutic goods
- reviewing manufacturing and testing data from companies to check that individual batches of vaccines and selected biological products comply with approved specifications before batches are released to the market
- providing scientific expertise to assess technical data for the registration and inclusion of therapeutic goods on the Australian Register of Therapeutic Goods (ARTG)
- providing administrative, scientific, and engineering advice to the TGA, expert committees, government, industries and consumers
- providing technical expertise for developing and maintaining national and international standards
- delivering training in testing techniques and other relevant regulatory functions.
The Laboratories Branch is also involved in a number of international activities.
Laboratory testing program
For more details on our testing program, see: Testing of therapeutic products
How we decide what to test
Our testing program is developed in consultation with other areas of the TGA and revised annually. The annual testing program identifies and prioritises selected therapeutic goods for testing while still allowing us capacity to respond quickly to emerging issues in the marketplace.
The testing program aims to:
- provide flexibility to investigate and test therapeutic goods in response to urgent public health and safety concerns
- target selected goods for testing to verify they meet the required quality as defined by legislation, official standards or agreed specifications
- provide capacity to test goods to provide test data to support investigations into problem reports and complaints
- provide capacity to test goods for accreditation, harmonisation, standardisation, quality assurance and international obligations
- prioritise testing requirements.
Samples for the testing program are obtained from sponsors, manufacturers, wholesalers, chemists, hospitals, retail outlets or consumers. On average our laboratories test around 1500 samples of products annually.
Compliance testing and problem investigation can involve analysing for the presence of contaminants, strength and potency, mechanical properties, electrical testing, and software analysis. Some products, such as vaccines, are tested frequently as a sub-potent batch can seriously affect the recipient's and the broader population's immunity to infection.
Market authorisation of therapeutic goods
Market authorisation refers to the process of evaluating and approving applications for new medicines and medical devices to be supplied in Australia.
Our laboratories support the Medicines Regulation Division and the Medical Devices Branch in evaluating and assessing information and data supplied in market authorisation applications to include therapeutic goods on the Australian Register of Therapeutic Goods (ARTG).
Laboratory staff evaluate information and data about:
- quality controls, manufacturing, testing and labelling for:
- vaccines
- cytokines
- blood products
- hormones and enzymes
- monoclonal antibodies
- other biological medicines
- the quality and performance of medical devices
- microbiological aspects of the manufacture of injectable products and other sterile therapeutic goods
- the endotoxin and cytotoxin safety of a wide range of medicines and devices
- technical aspects of applications to vary the information of therapeutic goods that are already included on the ARTG.
Our laboratory expertise
Our laboratory staff are qualified in a range of disciplines including:
- biochemistry
- biocompatibility
- biotechnology
- chemistry
- engineering
- materials science
- medical science
- pharmacology
- microbiology
- molecular biology
- veterinary science
- virology.
We also have expertise in identifying counterfeit medicines and in assessing the quality of herbal products and traditional complementary medicines.
Contract services
We provide testing and training services to other national regulatory authorities, international organisations and Australian government departments.
We only provide these services when the work is in line with our overall aims and objectives and when it does not involve any conflict of interest relating to our role in regulating therapeutic goods supplied in Australia.
Training offered to other national regulatory authorities is primarily focused on testing methods, quality assurance and laboratory management.
More information
For more information including laboratory testing, training programs and quotes please contact:
- Phone: +61 2 6289 4124
- Fax: +61 2 6203 1605
- Email: TGA.Laboratories@tga.gov.au