Guidelines for sterility testing of therapeutic goods

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13 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.

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