TGA Laboratories' guidelines for assessing the results of microbiological tests on non-sterile pharmaceuticals for human use
7 December 1994
Although this document is dated November 1994, it is still valid. Microbial limits is, however, the subject of a draft consultation paper about microbiological standards for the new Australia New Zealand Therapeutic Products Authority. Document last reviewed March 2006.
| Category | Type of Preparation | Suggested Limit |
|---|---|---|
| 1 | Products for Topical Application (including those for use in body cavities) | |
| 1a | For use on broken* and unbroken skin (other than antiseptics and corticosteroids) |
TAMC** not more than 102 per mL or per gram amongst which there should be
|
| 1b | Antiseptics and corticosteroids |
TAMC not more than 10 per mL or per gram amongst which there should be
|
| * "broken skin" refers to minor cuts and abrasions; products intended for use on large open wounds or severely damaged skin should be sterile. ** Total Aerobic Microbial Count |
||
| Category | Type of Preparation | Suggested Limit |
|---|---|---|
| 2 | Products for Oral Use | |
| 2a | Products other than those containing raw material of vegetable or animal origin |
TAMC not more than 103 per mL or per gram amongst which there should be
|
| 2b | Products containing raw materials of vegetable or animal origin |
TAMC not more than 104 per mL or per gram amongst which there should be
|
| 2c | Herbal teas |
TAMC not more than 105 per gram amongst which there should be
|