At its 167th session in June 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised version of the dosage form monograph on Parenteral preparations (0520) which gives mandatory quality requirements for a large number of medicinal products on the European market.
The revised text now describes the tests on particulate contamination – for both visible and sub-visible particles – in the test section as release criteria. These tests apply to all liquid parenteral preparations intended for injection or infusion (including solutions, suspensions, emulsions or gels). A reference to general chapter 5.17.2 has been included for additional guidance. This non-mandatory general chapter describes considerations used in the field of visual inspection and in the control of visible particles in medicinal products and provides guidance on how users can establish that their product is practically free from particles.
The test for visible particles has also been added to the production section to ensure that parenteral preparations are kept free from visible particles during manufacture.
Following a number of stakeholder comments, the original text has been expanded to include a new sub-section on intravitreal preparations, to clarify that they are parenteral preparations and not eye preparations. In line with requirements for all parenteral preparations in Europe, the bacterial endotoxin–pyrogen tests have been transferred from subsections to the general test section while maintaining the existing exception for veterinary products. For animal welfare reasons, the 10 ml injection volume recommendation for the pyrogen test has been deleted. Other additions include the introduction of uniformity requirements into the section on implants.
This was a general revision and many portions of the original text have been substantially overhauled. For example, the individual definition sections within the monograph have been modified and aligned with the relevant Standard Terms. As a result, injections are now clearly identified as liquid preparations that are usually administered as a bolus as opposed to infusions, which are administered slowly over a period of time. Further, in the section on injections, the term “clear” has been deleted to avoid any confusion with regard to opalescence or turbidity and the preparation method has been deleted to allow users greater freedom in their choice of method.
The revised chapter will be published in Supplement 10.5 of the Ph. Eur. by 1 January 2021 with an implementation date of 1 July 2021.