Therapeutic Goods Administration

Site

Laboratories Branch Immunobiology – Immunobiology

Accreditation No.

2432

Site No.

13549

Date of Accreditation

28 Jun 1999

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

Laboratories Branch Immunobiology – Immunobiology

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Biological analysis of human and veterinary medicines including vaccines Pharmaceuticals Endotoxin Limulus amoebocyte lysate (LAL)

By the Bacterial Vaccines method manual - Bacterial Endotoxin LAL

Vaccines Potency Cell culture; Direct inoculation; Enzyme linked immunosorbent assay (ELISA); Titration

By the Bacterial Vaccines method manual - Acellular Pertussis, Meningococcal, Tetanus

By the Viral Vaccines method manual - Cell Culture, Hepatitis B, Measles MMR, Rotavirus, Varicella

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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