GMP Pharmaceutical Testing Laboratory Australia

Intertek’s TGA GMP testing laboratory Australia is a leading GMP pharmaceutical testing lab, delivering reliable analytical testing services for pharmaceutical manufacturers, research organisations, biotechnology companies and regulatory programs. As a TGA and APVMA accredited pharmaceutical laboratory and US FDA inspected facility, Intertek’s West Footscray team provide high-quality testing services that support product release, regulatory submissions, stability programs and manufacturing investigations.

Trusted Pharmaceutical Analytical Testing Services Across Australia

With more than 35 years of pharmaceutical analytical expertise, our scientific team combines deep technical capability with a strong culture of quality and continuous improvement. From routine pharmaceutical QC testing to complex method development and validation, our Melbourne GMP laboratory, located in West Footscray, Victoria, Australia delivers accurate, compliant and defensible results that customers can rely on.

Our TGA compliant pharmaceutical testing services supports clients seeking an Australian pharmaceutical contract laboratory partner, including companies requiring GMP pharmaceutical stability testing lab Melbourne services, TGA compliant API testing support.

Previously known as PROBE, the Intertek West Footscray laboratory has a heritage as ICI Australia’s Research Group Analytical Services and has been providing high quality analytical support to research and development projects since 1951.

Why Pharmaceutical Companies Choose Intertek Australia

• Our TGA GMP laboratory Australia has 35+ years of pharmaceutical analytical testing and TGA compliant pharmaceutical testing services and is US FDA inspected (Intertek Testing Services Australia).
• Our Australian contract analytical laboratory operates to ISO 9001.
• Advanced analytical instrumentation including experience partner for HPLC testing Australia plus UPLC, GC, GC-MS, UV, ICP, ICP-MS, AAS, FTIR, SEM and NMR.
• Extensive experience in traditional wet chemistry techniques and methods in accordance with published Pharmacopoeia: USP, BP, EP.
• Specialist expertise in pharmaceutical method development, validation and is the location of our stability testing laboratory Australia
• Flexible lab resources supporting all sizes of requests: from single sample one-off requests through to larger ongoing projects
• Responsive technical support and fast turnaround times for critical manufacturing investigations

Comprehensive Contract Pharmaceutical Testing Services

As one of the most capable pharmaceutical chemistry laboratories in Australia, Intertek provides a complete range of TGA compliant pharmaceutical testing services across Australia, New Zealand and Worldwide. Intertek West Footscray is part of the global Intertek Pharmaceutical Services lab network.

Raw Materials Testing

Intertek’s Australian pharmaceutical contract laboratory performs comprehensive testing of active pharmaceutical ingredients (APIs), excipients and incoming raw materials to ensure compliance with pharmacopoeial and regulatory requirements. Our API testing laboratory Australia services support both routine quality control and complex investigations.

Finished Product Testing

Our pharmaceutical QC testing Australia services include assay, impurities, dissolution, disintegration, residual solvents, elemental impurities and release testing for finished pharmaceutical products. As a GMP analytical laboratory Australia manufacturers trust, our results can be used for batch release and regulatory submissions.

Stability Testing

Intertek’s Australian pharmaceutical stability testing laboratory operates modern walk-in and cabinet stability chambers supporting ICH and FDA protocols. Our stability testing laboratory Australia services include accelerated, long-term, in-use and commercial stability studies for pharmaceutical and veterinary products.

Method Development and Validation

We are proven experts in pharmaceutical method development, verification and validation, delivering trusted method development and validation Australia services for local and global pharmaceutical companies. Our scientists develop robust analytical methods tailored to customer products, processes and regulatory requirements while ensuring compliance with GMP and data integrity expectations.

Manufacturing Investigation Support - Impurity identification 
Our scientists provide impurity identification and quantification using validated analytical techniques to support evolving global regulatory requirements and risk mitigation programs for process impurities, organic impurities and elemental impurities. Additionally, we have a proven track record of rapid response in contaminant identification supporting manufacturing investigations: helping to understand and eliminate process/production issues.

Advanced Technology and Specialist Expertise

Our laboratories utilise state-of-the-art instrumentation across a wide range of analytical techniques, including HPLC, UPLC, GC, GC-MS, UV, ICP, ICP-MS, AAS, FTIR, SEM, NMR and dissolution and disintegration testing systems. We are equally experienced working with established pharmacopoeial methods and implementing advanced analytical technologies for emerging pharmaceutical products.

Our highly trained scientists support a diverse range of industries including pharmaceutical, veterinary, cosmetic, food, polymer, agricultural and specialty chemical manufacturing.

Driven by Quality and Continuous Improvement

Reliable pharmaceutical testing requires more than instrumentation alone. At Intertek, our testing and management systems are designed around modern GMP principles, data integrity compliance and scientifically robust validation practices.

As a trusted contract pharmaceutical testing lab Australia manufacturers rely upon, we understand the critical importance of accurate analytical data in protecting patient safety and supporting regulatory compliance. Our commitment to quality, responsiveness and technical excellence has made Intertek a preferred analytical partner for pharmaceutical manufacturing and biotech companies in Australia and across the world.