29 September - 1 October 2020
Prague, Czech Republic
The new chapter 5.17.2 in the European Pharmacopoeia "Recommendations on testing of particulate contamination: visible particles" was already published for comment in autumn 2018 (Pharmeuropa 30.4). The comments and feedback received have been considered by the Expert Group 12 of the EDQM and the chapter has now come into force.
The chapter is not binding, but has a recommendatory character and contains information on the visual inspection of medicinal products intended for injection. The inspection itself is further described in chapter 2.9.20. Various sources of foreign particles are discussed and visual inspection is considered in the context of manufacturing and quality control, including stability testing. The AQL inspection after completion of the 100% inspection (refering to ISO Standard 2859-1) is also addressed. The new chapter reflects the probabalistic nature of visual inspection of particles and provides guidance on how to deal with the requirement of "practically free of particles". A similar approach, with less practical details, can also be found in the US-American Pharmacopoeia USP in chapter <1790>.
The new chapter will be published in the European Pharmacopoeia (Ph. Eur.) Supplement 10.3 and will come into force on 1st January 2021.