
National Association of Testing Authorities, Australia
Scope of Accreditation
Therapeutic Goods Administration
Site
Laboratories Branch – Microbiology, Chemistry and Biotherapeutics
Accreditation No.
2432
Site No.
2664
Date of Accreditation
01 Jun 2017
Contact
Availability
Services conditionally available to external clients
Scope of Accreditation
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 11897 MSP Library Version 12) |
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 | Aerobes - Total viable | Membrane filter | in-house method MM02-115 | |
Aerobes - Total viable | Qualitative | in-house method MM02-115 | ||
Pseudomonads | Qualitative | in-house method MM02-115 | ||
Test for sterility | Direct inoculation | BP Appendix XVI A (in-house method MM02-49) | ||
Staphylococcus aureus; Staphylococcus spp. | Qualitative | in-house method MM02-115 | ||
Preservative efficacy | Spread plate | BP Appendix XVI C, USP-NF 51, ISO 14730 (in-house method MM02-119) | ||
Aerobes - Total viable | Spread plate | in-house method MM02-115, 122 | ||
Anaerobes | Qualitative | in-house method MM02-115 | ||
Escherichia coli | Qualitative | in-house method MM02-115 | ||
Medical devices; Pharmaceuticals | Test for sterility | Membrane filter | BP Appendix XVI A (in-house method MM02-49) | |
Medicinal preparations; Pharmaceuticals | 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) | |
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) | ||
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 | ||
Osmophilic yeasts | Qualitative | 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) |
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 |
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 |
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 11897 MSP Library Version 12) |
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) |
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
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Accreditation No.
2432
Site No.
2664
Print date
18 Feb 2025