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
For verification methods, see validation.