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Featured Technical Article

Pharmaceutical Microbiology – USP General Chapters

Author: Shelia Hinnant

In an effort to harmonize with the European Pharmacopeia and the Japanese Pharmacopeia, the USP revised the USP chapter on Microbial limits testing.   Although the effective date for the revisions was delayed until May of 2009, the changes are significant enough to require revalidation in some cases.   Thus, many companies are already performing the new methods to ensure compliance by the date of implementation.

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