PT  - JOURNAL ARTICLE
AU  - Shelley Tang
TI  - Microbial Limits Reviewed: The Basis for Unique Australian Regulatory Requirements for Microbial Quality of Non-Sterile Pharmaceuticals
DP  - 1998 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 100--109
VI  - 52
IP  - 3
4099  - http://journal.pda.org/content/52/3/100.short
4100  - http://journal.pda.org/content/52/3/100.full
SO  - PDA J Pharm Sci Technol1998 May 01; 52
AB  - 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.