Glossary
Microbial Limits
Microbiological acceptance criteria a product must meet, such as total aerobic count, total yeast and mould count, and absence of specified objectionable organisms.
Source · ICH Q6A (1999), §3.3.1(g) Microbial limits
Details
These criteria apply to products for which sterility is not required, and alongside total counts and yeast and mould they specify the absence of particular objectionable organisms such as Staphylococcus aureus, Escherichia coli, Salmonella, and Pseudomonas aeruginosa. Because the limits depend on the nature of the product, the way it is made, and its intended use, numbers cannot simply be carried over from another product. The corpus cites compendial monograph specifications and microbial limits not carried into the specification document, water that failed to meet its limits, and batch records missing the microbial limit test data.
Related sections
Related terms
Real inspection findings
See 6 findings whose text contains this termCounted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q6A (1999), §3.3.1(g) Microbial limitsGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
Browse the whole glossary