Internationally harmonised methods for microbiological examination of non-sterile products Part 2:: Practical experiences relating to the quantitative determination of specified micro-organisms and comments to the microbiological quality using herbal medicinal products

The following experiences and comments can be made on the basis of knowledge acquired with respect to the testing of products and the acceptance criteria in accordance with the harmonised microbiological methods in 6th Supplement to the European Pharmacopeia 5th edition (Ph.Eur. 5.6) using herbal medicinal products: When testing for bile-tolerant gramnegative bacteria, less selective evaluation may result in increased findings. Plate-count methods should be used for determination of bile-tolerant gram negative bacteria and Escherichia coli in herbal medicinal products as an alternative to the described PN (probable number) methods. The acceptance criteria for the microbiological quality of non-sterile dosage forms have been lowered in practical terms by changing the factor of interpretation from 5 to 2. It would be possible to define special methods and acceptance criteria for herbal medicinal products in Europe without contradicting the idea of harmonisation.