In which chapters of the European Pharmacopoeia are microbiological criteria for non-sterile pharmaceutical dosage forms included?
Microbiological criteria are included in several chapters of the Ph.Eur. Chapter 5.1.4 contains the acceptance criteria for non-sterile dosage forms (Table 1) as well as for raw materials used in their production (Table 2). Chapter 5.1.8 contains the acceptance criteria for herbal medicinal products for oral use.
Furthermore, many monographs of individual substances include specific acceptance criteria for microbiological quality.
