Microbial Limits Reviewed: The Basis for Unique Australian Regulatory Requirements for Microbial Quality of Non-Sterile Pharmaceuticals

Abstract

The need to retain Australian regulatory requirements for non-sterile pharmaceutical products has been questioned following publication of guideline limits in the 1996 Addendum to the British Pharmacopoeia (BP). The Therapeutic Goods Administration (TGA) contends that, in some respects, the BP limits, formulated by the European Pharmacopoeial Commission, do not provide for adequate patient safety. The case for retention of TGA guidelines is based on laboratory investigation into the microbial quality of product groups on the Australian market, and an assessment of the risk to patients of microbial contamination in pharmaceutical products which are not manufactured as sterile.