TGA guidelines for sterility testing of therapeutic goods
September 2006
This document provides guidance for sterility testing of sterile therapeutic drugs and devices supplied in Australia for human use. They are intended for use by manufacturers and the Official Analyst of the Therapeutic Goods Administration (TGA) Laboratories, and as guidance for referee testing when results are in dispute. The guidelines have been updated to reflect the changes made to the British Pharmacopoeia sterility test method.
TGA guidelines for sterility testing of therapeutic goods (2006) (pdf,182kb)
Contents
- Introduction
- Regulatory aspects
- Rationale
- Sampling of lots
- Precautions against microbial contamination
- Test methods
- General methodology
- Method of membrane filtration
- Method of direct transfer
- Records
- Media for use in sterility testing
- Composition
- Method of preparation
- Tests on the media
- Shelf-life
- Diluents, solvents and wash solutions
- Composition
- Method of preparation
- Tests on diluents, solvents and wash solutions
- Shelf-life
- Annex I Guidance on obtaining small numbers of vegetative organisms and spores
- Annex II Composition and preparation of media
- Annex III Composition and preparation of diluents
- Annex IV Sterility test environment