Therapeutic Goods Administration

Site

Laboratories Branch – Microbiology, Chemistry and Biotherapeutics

Accreditation No.

2432

Site No.

2664

Date of Accreditation

21 Dec 1986

Address

1 Tindal Lane
Canberra Airport, ACT 2609
Australia

tga.gov.au

Contact

Ms Erin Fitzgerald P: +61 (02) 62894107

Availability

Services conditionally available to external clients

Therapeutic Goods Administration address map

Scope of Accreditation

Print scopes
Laboratories Branch – Biotherapeutics

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Biological analysis of human and veterinary medicines including vaccines Biological medicines; Vaccines Content; Identity; Potency; Purity Cell culture; Chromatography; Coagulation; Electrophoresis; Enzyme activity; Enzyme linked immunosorbent assay (ELISA); Immunodiffusion; Mass spectrometry (MS); Polymerase chain reaction (PCR)

By BP, PhEur, USP, manufacturer and in-house methods for Capillary electrophoresis, Cell culture, Electrophoresis, ELISA,  Enzyme activity, General laboratory procedures, HPLC, Influenza, PCR and Sysmex
Pharmaceuticals LAL bacterial endotoxin Limulus amoebocyte lysate (LAL)

By BP, PhEur, USP, manufacturer and in-house methods for Bacterial Endotoxin
Laboratories Branch – Chemistry

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Analysis for physical and chemical characteristics of human and veterinary medicines including vaccines Antibiotics; Compounding pharmaceuticals constituents; Drugs; Medicinal preparations; Vitamins Disintegration; Dissolution; Particle size; Specific gravity; Uniformity of weight; pH HPLC; Light obscuration; UV-vis spectrophotometry; Visual examination

By AS, BP, PhEur, USP, Manufacturers' Standards and in-house method LB
Identification - Qualitative of active ingredients and other components GC-MS; Gas chromatography (GC); HPLC; Infrared spectrophotometry; Ion chromatography (IC); LC-MS; Thin layer chromatography (TLC); UV-vis spectrophotometry; Ultra performance liquid chromatography (UPLC); Visual examination

By AS, BP, PhEur, USP, Manufacturers' Standards and in-house method LB
Analysis - Quantitative GC-FID; GC-MS; Gas chromatography (GC); HPLC; Ion chromatography (IC); LC-MS; Microwave plasma - Atomic emission spectroscopy (MP-AES); Polarimetry; Titration; UV-vis spectrophotometry; Ultra performance liquid chromatography (UPLC)

By AS, BP, PhEur, USP, Manufacturers' Standards and in-house method LB
Laboratories Branch – Microbiology

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Analysis for microorganisms Bacterial isolates; Yeast isolates Identification MALDI-TOF in-house method MM02-78 (Bruker MBT RUO 12438 MSP Library Version 13)
Biological analysis of human and veterinary medicines including vaccines Medical devices Pyronema domesticum Qualitative selective enrichment

in-house method MM02-115
Medical devices; Medicinal preparations; Pharmaceuticals Pseudomonads Qualitative

in-house method MM02-115
Staphylococcus aureus; Staphylococcus spp. Qualitative

in-house method MM02-115
Aerobes - Total viable Qualitative

in-house method MM02-115
Escherichia coli​​​​ Qualitative

in-house method MM02-115
Test for sterility Direct inoculation

BP Appendix XVI A (in-house method MM02-49)
Aerobes - Total viable Membrane filter

in-house method MM02-115
Anaerobes Qualitative

in-house method MM02-115
Aerobes - Total viable Spread plate

in-house method MM02-115, 122
Preservative efficacy Spread plate

BP Appendix XVI C, USP-NF 51, ISO 14730 (in-house method MM02-119)
Medical devices; Pharmaceuticals Test for sterility Membrane filter

BP Appendix XVI A (in-house method MM02-49)
Medicinal preparations; Pharmaceuticals Aerobes; Yeasts and moulds Membrane filter

BP Appendix XVI B, EP, USP-NF 61, USP-NF 62 (in-house method MM02-115)
Salmonella spp. Qualitative

in-house method MM02-115
Lactobacillus spp. Spread plate

in-house method MM02-118
Aerobes; Yeasts and moulds Spread plate

BP Appendix XVI B, EP, USP-NF 61 and USP-NF 62 (in-house method MM02-115)
Osmophilic yeasts Qualitative

in-house method MM02-115
Candida albicans; Clostridium spp.​​​​; Escherichia coli​​​​; Pseudomonas aeruginosa; Staphylococcus aureus; Bile tolerant gram negative bacteria Qualitative

BP Appendix XVI B, EP, USP-NF 61, USP-NF 62 (in-house method MM02-115)
Biological analysis of other healthcare or pharmaceutical products and accessories Disinfectants Efficacy Antimicrobial suspension TGA Disinfectant Test (in-house method MM09-96, 105)

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