August 2018

  Whenever new standards or regulations are put in place, it’s important to understand who developed them, what they are, and why they were developed.  The goal of the United States Pharmacopoeia (USP), the organization behind USP <800>, is “to improve global health through public standards and related programs that help ensure the quality, safety, […]

  While all three chapters address cleanrooms, USP <795> is the first (of two) to have its revisions made public and, accordingly, provides facility owners with the first opportunity to provide public comment or seek clarification. Section four of the Proposed Revision to GC <795>, which covers Buildings and Facilities, states: Compounding facilities must have