TGA Laboratory Testing of Therapeutic Goods: Quality Assurance and Safety Monitoring

1. Overview of TGA Testing

The Therapeutic Goods Administration (TGA) Laboratories conduct testing of therapeutic goods, including medicines, medical devices, and biologicals, using a risk-based approach to ensure quality and safety. Approximately 2000 samples are tested annually, sourced from manufacturers, wholesalers, hospitals, retail outlets, or the public. Testing verifies compliance with quality criteria or, for medical devices, the Essential Principles. It assesses contaminants, strength, potency, mechanical/electrical properties, software, and identifies counterfeits. Special focus areas include biological medicines (e.g., vaccines), herbal products, and complementary medicines. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/product-testing-and-investigations/testing-therapeutic-goods

A single sample's quality is assumed representative of its batch if stored correctly, but testing does not replace GMP compliance or pre-market assessments.

2. Testing Methodology

Laboratory operations follow a Quality Management System (QMS), standard procedures, and NATA accreditation (ISO/IEC 17025 compliance). Samples are managed under specific policies, with tracking via a Laboratory Information Management System (LIMS). Ongoing research develops new testing methods to maintain relevance and reliability. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/product-testing-and-investigations/testing-therapeutic-goods

3. Categories of Testing

• Responsive Testing: Prioritizes products with identified issues (e.g., complaints, adverse events) for rapid public safety response. Non-compliance may trigger recalls or further action.
• Programmed Testing: Monitors market compliance through surveys, risk assessments, or following GMP inspections/international alerts.
• Maintenance Testing: Develops and validates methods, trains staff.
• Support to External Agencies: Includes WHO collaboration as a designated centre for vaccine quality assurance. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/product-testing-and-investigations/testing-therapeutic-goods

4. Testing of Biological Medicines

Biologicals undergo risk-based surveys and batch release testing against approved specifications. Vaccine batch release requires sponsor documentation and samples. Non-vaccine biologicals may involve documentation evaluation or annual reports. Testing covers identity, strength, purity, and potency (not clinical efficacy). Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/product-testing-and-investigations/testing-therapeutic-goods

5. Testing Unregistered Goods

Unregistered products (e.g., from complaints, border seizures) are tested for undeclared or prohibited ingredients. Passing tests does not grant registration; such goods may be prohibited imports and destroyed. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/product-testing-and-investigations/testing-therapeutic-goods

6. Standards and Outcomes for Failed Tests

Testing uses pharmacopoeial standards (BP, EP, USP), Therapeutic Goods Orders, or certified details. Medicines are assessed for identity, content, purity, activity, and microbiology. Medical devices for Essential Principles compliance. Failures trigger risk-based responses: advice, recalls, restrictions, or ARTG cancellation. Most prescription medicines comply (~0.5% failure rate), with higher rates for OTC and Complementary Medicines. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/product-testing-and-investigations/testing-therapeutic-goods

7. Available Test Methods

Specific methods include screening for nicotine in e-liquids, prohibited ingredients in vaping products, and cannabinoids. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/product-testing-and-investigations/testing-therapeutic-goods