Samples are analysed for the presence of microorganisms in general and specific pathogenic microorganisms.

Samples from non-sterile production is analysed according to the following pharmacopoeia:

• Ph. Eur. 5.1.4. Microbiological Quality of Non-sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use
• Ph. Eur. 2.6.12/USP<61> Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests
• Ph. Eur. 2.6.13/USP<62> Microbiological Examination of Non-sterile Products: Test for Specified Micro-organisms.

Samples from production of herbal medicine is analysed according to the following pharmacopoeia:

• Ph. Eur. 5.1.8. Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation
• Ph. Eur. 2.6.31. Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation

Examples of microbiological purity tests:

• Total aerobic microbial count (TAMC)
• Total combined yeast/molds count (TYMC)
• Bile-tolerant gram-negative bacteria
• Escherichia coli
• Salmonella sp
• Staphylococcus aureus
• Psedomonas aeruginosa
• Candida albicans
• Clostridia

For verification methods, see validation.