USP <1111> - Microbiological Examination of Nonsterile Products: Acceptance Criteria

What it says

This general information chapter provides recommended acceptance criteria for the microbiological quality of nonsterile pharmaceutical preparations and substances, expressed as limits on total aerobic microbial count and total combined yeasts and molds, and the absence of specified objectionable organisms, varying with the route of administration.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It is used together with the enumeration and specified microorganism tests in USP <61> and USP <62>.
• Acceptance criteria vary with the route, for example oral, topical or inhalation, because the risk differs.
• Firms still need to assess which organisms are objectionable for their particular product.

What inspectors look for

• Whether microbial limits are defined and tested for nonsterile products.
• Whether limits are appropriate for the route of administration.
• Whether results over limits are investigated.

Related regulations