
National Association of Testing Authorities, Australia
Scope of Accreditation
Therapeutic Goods Administration
Site
Laboratories Branch Biochemistry – Biochemistry
Accreditation No.
2432
Site No.
2665
Date of Accreditation
30 Jun 1989
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 |
---|---|---|---|---|
Biological analysis of human and veterinary medicines including vaccines | Anti-coagulants; Blood products; Cytokines; Enzymes; Heparin; Hormones; Monoclonal antibodies; Plasma products | Content; Identity; Potency | Chromatography; Coagulation; Electrophoresis; Enzyme activity; Enzyme linked immunosorbent assay (ELISA); Mass spectrometry (MS) |
By the methods in capillary electrophoresis manual, electrophoresis manual, enzyme activity manual, general laboratory methods manual, HPLC manual, Sysmex manual |
Biological medicines | Purity | Chromatography; Electrophoresis; Enzyme linked immunosorbent assay (ELISA); Mass spectrometry (MS); Polymerase chain reaction (PCR) |
By the methods in capillary electrophoresis manual, electrophoresis manual, general laboratory methods manual, HPLC manual, PCR manual |
|
Cytokines; Hormones; Monoclonal antibodies | Bioassay; Potency | In-vitro assays; In-vivo assays |
By the methods in bioassay manual, cell culture manual, general laboratory methods manual |
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.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
2432
Site No.
2665
Print date
29 Jun 2022