USP revised about thirty Ophthalmic Ointment Monographs
Recommendation
6/7 May 2025
Challenges and Solutions for Packaging / Devices & Single Use Systems
On July 29, 2016, the United States Pharmacopeia (USP) posted a new Revision Bulletin regarding approximately thirty Ophthalmic Ointment Monographs.The revised monographs became official on August 1, 2016.
The USP Chemical Medicines Expert Committees 1 to 6 have revised the monographs following the revision of general chapter <771> which became official on May 1, 2016 (USP 39).
The purpose of the revision is to replace the requirement to comply with the entire content of the USP general chapter Ophthalmic Products—Quality Tests <771> (whose former title was Ophthalmic Ointments) with a requirement to comply only with the subsection for Particulate and Foreign Matter in Ophthalmic Products—Quality Tests <771>, and with the section for Container Content for those monographs where the requirement for Minimum Fill was deleted.
The Revision Bulletins for the respective monographs supersede the currently official version of these monographs. The Revision Bulletin will be incorporated in the First Supplement to USP 40–NF 35.
For more information please visit the USP Revision Bulletins website.
Related GMP News
15.01.2025English Translation of Supplement II to the Japanese Pharmacopoeia (JP18) Published
08.01.2025EDQM publishes new FAQ on System Suitability Test (SST)
08.01.2025Pharmeuropa Chapter 2.1.7. Balances for Analytical Purposes published for Comments
08.01.2025How to Guarantee a Complete FDA Inspection Failure
11.12.2024Another FDA Warning Letter Based on Review of Records