Acceptance criteria for non-sterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts/moulds count (TYMC) are given in the table on the screen.
When an acceptance criterion for microbiological quality is prescribed, it is interpreted as follows:
- 101 cfu: maximum acceptable count = 20
- 102 cfu: maximum acceptable count = 200
- 103 cfu: maximum acceptable count = 2000, and so forth.
This table includes a list of specified microorganisms for which acceptance criteria are set.
The list is not necessarily exhaustive, and for a given preparation it may be necessary to test for other microorganisms depending on the nature of the starting materials and the manufacturing process.