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The various national pharmacopeial organizations have been working toward a global harmonization of various methods and tests for several years. Although the test limits for liquidborne particles in injectables has been equivalent for many years, the methods of testing were similar but not equivalent. The USP had intended to harmonize their method with the EP 2.9.19 test in 2008 but this effort has been accelerated to take effect on 1 April 2007. This change has been made under an Interim Revision Announcement (IRA). An IRA can be set to any schedule deemed appropriate by the USP Expert Committee in charge of that specific method or test.
Due to a range of harmonization effects and impacts, the USP has delayed the release of their updated version of the US Pharmacopeia; it should have switched from USP 29 to USP 30 on 1 January 2007. However, the official change to USP 30 will occur on 1 May 2007 so USP 29 is official until 30 April 2007.
To view the Webinar click on this link.
To request a copy of the presentation please send an email to infogp@hachultra.com, with USP 788 in the subject line.
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