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...
What a week it’s been @ #ASHP2023 Midyear! As we reflect on the highlights of Midyear, we’re filled with gratitude for the opportunities ASHP2023 presented. Here’s to leveraging these experiences for future achievements and continued excellence!...
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