Therapeutic Goods Administration

Site

Laboratories Branch Biochemistry – Biochemistry

Accreditation No.

2432

Site No.

2665

Date of Accreditation

30 Jun 1989

Address

136 Narrabundah Lane
Symonston , ACT 2609
Australia

tga.gov.au

Contact

Ms Erin Fitzgerald P: +61 0417808607

Availability

Services conditionally available to external clients

Scope of Accreditation

Print scopes
Laboratories Branch Biochemistry – Biochemistry

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.