Notes on USP36-NF31 <1116 - Microbiological Evaluation of Cleanrooms and Other Controlled Environments>

The USP is the United State’s Pharmacopeia.

If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation.  For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use.

The latest iteration of this section of the USP is 39-NF34,  The last version I managed to get my hands on was USP36 NF31.  I’ve compared the two and noted the changes from the NF I reviewed initially.  The identified changes are in blue.

Same as other post, but with changes.

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