At its 165th session in November 2019, the European Pharmacopoeia Commission adopted two general chapters related to testing for particulate contamination in pharmaceutical preparations.
The revisions to general chapter 2.9.19. Particulate contamination: sub-visible particles supplement the Pharmacopoeial Discussion Group (PDG) harmonised text with alternative local requirements applicable to biological parenteral preparations. Such preparations are provided in low volumes and the local requirements – marked in the text with white diamonds – allow testing of these and other preparations to be performed using volumes smaller than 5 mL where suitable instrumentation is available. The PDG remains committed to further revising the chapter in order to integrate these changes into the harmonised text.
The new, non-mandatory general chapter 5.17.2. Recommendations on testing of particulate contamination: visible particles provides information on visual inspection and control of visible particles in liquid preparations for which testing according to the general chapter 2.9.20. Particulate contamination: visible particles applies. The text highlights the different sources of foreign particle contamination of liquid preparations and the fact that every effort should be made to avoid their presence. Consideration is given to the different inspection stages during production and quality control, including stability testing. Acceptable quality level (AQL) testing (with reference to ISO standard 2859-1) following a 100% inspection of the batch is also addressed. This chapter is not intended to elaborate on GMP requirements, but rather should be read in conjunction with them. Detection of visible particles in parenteral products is probabilistic in nature and the occurrence of particles is random. The chapter therefore provides guidance on how users can establish that their product is “practically free from particles”.
These two chapters will be published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3 and will become effective on 1 January 2021.