Facility Design and Construction Requirements | USP 795 & 797 Revisions It is important to note that there have been significant changes made to the regulations governing Nonsterile Preparations and Sterile Preparations. These changes are outlined in USP General...
Sterility Testing | USP 795 & 797 Revisions The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because of irresolvable limitations in testing” (USP <1211> Sterility Assurance). These...
Beyond-Use Dates | USP 795 & 797 Revisions The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797) preparations. Included in these revisions were updates to the beyond-use dates (BUDs) to clarify topics that...
Antimicrobial Effectiveness | USP 795 & 797 Revisions Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple–dose products. Antimicrobial effectiveness should...
Water Activity | USP 795 & 797 Revisions The new practice of using water activity as a tool for establishing the BUD of a CNSP is described in Section 10.3 of the to-be-official USP <795> chapter. Water activity testing in accordance with USP <922> is...
Cleanroom Certification | USP 795 & 797 Revisions A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six months and/or after any changes to the classified area including construction,...
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