Special Edition Pharmaceuticals No. 1: Assessment of Critical Microorganisms in Non-Sterile Pharmaceutical Products (= Objectionable Microorganisms) - Part 1
May 31, 2017 - Laboratory
Special Edition Pharmaceuticals No. 1: Assessment of Critical Microorganisms in Non-Sterile Pharmaceutical Products (= Objectionable Microorganisms) - Part 1
The examination of non-sterile products, such as tablets, capsules, powders, ointments, or inhalation products, is generally conducted according to chapters 2.6.12 and 2.6.13 of the European Pharmacopoeia (Ph. Eur.) and the acceptance criteria of chapter 5.1.4 are recommended. The methods and requirements described there are considered harmonized with the United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP) (ICH Q4B 2007). They were officially introduced in 2006 and have been in effect in Europe since 2009.