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Date: 9th February, 2010

Location: On-Line, USA

Summary:
Pharmaceutical - Web Seminar

Click here to Register for this Seminar

The Microbial Limits Tests of the three major pharmacopeia are in the final processes of harmonization and are scheduled to be fully implemented in 2009. These provide guidance on compendial testing of bioburdens and specified organisms and guidance on setting specifications. This presentation will cover the tests in board overview and discuss the differences between compendial tests for specified organisms and the manufacturer's obligation to minimize the presence of objectionable organisms.

Areas Covered in the Seminar:

• What is involved in the new MLT?
  


• Harmonization Status.
  


• Differences in new 'Microbial Enumeration' test <61>.
  


• Differences in new 'Absence of Specified' test <62>.
  


• Differences in new <1111>.
  

Understanding the Harmonized Microbial Limits Tests