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.