29 September - 1 October 2020
Prague, Czech Republic
After the long-awaited Chapter <1790> Visual Inspection of Injections was first published in the Pharmacopeial Forum 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Through its number >1000, the monograph <1790> is not binding but rather offers an explanation to Chapter <790> Visible Particulates in Injections.
With regard to the content, several comments recommended by the industry have been included. The new Chapter 9 represents the biggest change and describes the evaluation of marketed products where anomalies had been observed regarding particles. The test procedure for it is described in Chapter <790>. Yet, this topic was missing in the original draft of Chapter <1790>. Thus, in total there is one more chapter. In addition, the underlying test statistics contained in the chapter on inspection of lyophilised product have been detailed. The requirements on the premises for manual inspection have also been added in more detail. Moreover, a clear statement can be found on the validation of a fully automatic system which should be based on the comparison with the compendial manual inspection.
The draft document is available for free on the website of the USP Pharmacopeial Forum. You only need to register for free. The deadline for comments is 31 Januar 2016. The new chapter could be published in the USP 40 in November 2016 and becomes effective as of May 2017. A document comparing the original and the second draft can be found on the website of ECA's Visual Inspection Group, under useful links.