AUSTRALIA TGA RELEASES UPDATED STERILITY TESTING GUIDANCE

Australia's Therapeutic Goods Administration (TGA) has issued updated guidance on sterility testing of drugs and devices. It is intended for use by manufacturers and TGA laboratory analysts, and as guidance for referee testing when results are disputed. The document has been updated to reflect changes made to the British Pharmacopoeia sterility test method.

The guidance is based on the "Australian Code of Good Manufacturing Practice for Therapeutic Goods -- Medicinal Products -- Appendix C Guidelines on Tests for Sterility" and also incorporates requirements of the British Pharmacopoeia and the European Pharmacopoeia, with additional elements from the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme Recommendations on Sterility Testing, the U.S. Pharmacopoeia and the combined experience of the TGA laboratories and Australian manufacturers.

Though the document may describe particular procedural steps and methods, it should be understood that other procedures and methods may be satisfactory, provided they can be validated, according to the TGA. However, when the results of a sterility test performed by a TGA analyst are challenged, the combined procedures of the British/European test and the document must be followed.