Tuesday, 20 August 2013

USP Chapter 1115 Bioburden Control

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.

*See: Sandle, T. (2012). Review of FDA warning letters for microbial bioburden issues (2001-2011), Pharma Times, Vol. 44, No.12, pp29-30

Posted by Tim Sandle