Tang S
Therapeutic Goods Administration Laboratories, Canberra, Australia.
PDA J Pharm Sci Technol. 1998 May-Jun;52(3):100-9.
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.
在《英国药典》（BP）1996年增补中公布指导限值之后，对于保留澳大利亚非无菌药品监管要求的必要性产生了质疑。澳大利亚治疗用品管理局（TGA）认为，欧洲药典委员会制定的BP限值在某些方面未充分保障患者安全。保留TGA指南的依据是对澳大利亚市场上各类产品微生物质量的实验室调查，以及对非无菌生产的药品中微生物污染对患者造成风险的评估。
