After
several years of discussion and debate the United States Pharmacopeia (USP) has
issued a draft of a proposed new chapter: USP <1115> “Bioburden Control
of Nonsterile Drug Substances and Products”. The draft has been released in the
Pharmacopeial Forum July/August, 2013.
By
appearing in the Pharmacopeial Forum the draft chapter is presented to the
industry for comment, with a view to a final chapter being published sometime
in 2014. The main basis to the chapter is the setting out of a risk-based
approach to monitor and control of the manufacturing facility and process for
non-sterile pharmaceutical products. These are important concerns for bioburden
has been cited by the U.S. FDA in several warning letters over the past ten
years in relation to batch rejection and recall*.
Scott
Sutton has more information about the new chapter,
including a link to a copy on the Microbiology Network: to view please click here.
Posted by Tim Sandle
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