Revised USP Chapter on Visual Inspection published

After the long-awaited Chapter <1790> on visual inspection of injections was first published in the PF 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Read more about the revised draft of the USP Chapter <1790>.

http://www.gmp-compliance.org/enews_05091_Revised-USP-Chapter–1790–on-Visual-Inspection-published_15154,Z-PEM_n.html

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…