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USP 797

USP Compliance It's as Easy as A, B, C,..1, 2, 3, Or is it?

USP <797> Compliance: It’s as Easy as A,B,C…1,2,3. Or is it?

Building Sciences /

Aspergillus, Bacillus, and Cladosporium – The Importance of Genus Identification  The revised USP <797> standards for compounded sterile preparations (CSPs) have arrived, and they’re causing a stir in the pharmaceutical world. Adherence to the new standards will require more effort from compounding pharmacies, especially in areas such as documentation. These Standard Operating Procedures (SOPs) are […]

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USP Personnel Competency Q&A

USP <797> Personnel Competency Q&A

Building Sciences /

On September 18, Dr. Michael Berg, Technical Director Pace® Building Sciences, and Rhonda Lintner, Pace® Account Executive, presented a webinar on the USP <797> Personnel Competency requirements.   Watch On-Demand: USP <797> Personnel Competency and Environmental Monitoring  After the formal presentation, Michael and Rhonda answered numerous practical questions from attendees. In addition, we received several more

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Demonstrating USP Surface Sampling Competency

Demonstrating USP <797> Surface Sampling Competency

Building Sciences /

In 2023, the USP <797> standard for compounded sterile preparations was significantly revised to improve patient safety. Not only are there more protocols to follow, but pharmacies may need to demonstrate their adherence to USP <797> to various Authorities Having Jurisdiction (AHJ). Proving adherence includes documenting standard operating procedures (SOPs), but it also includes providing

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10 Tips for Proper Shipping of USP <797> Samples

Building Sciences /

The 2023 revisions to USP <797> increase compliance requirements for compounding pharmacies. Following proper handling and shipping procedures for lab media can help ensure all that extra effort doesn’t go to waste. Here are ten tips for ensuring your gloved fingertip and surface samples arrive safely. 1. Label samples on the bottom or base of

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USP 797 BUDs: How the 2023 Changes Impact Environmental Monitoring Requirements

Analytical + Environmental /

In November 2023, significant revisions to the United States Pharmacopeia (USP) General Chapter <797> will go into effect, bringing critical updates to the environmental monitoring standards governing the compounding of sterile preparations. In this post, we delve into the changes to USP 797 BUD standards and how they impact environmental testing requirements. For more information

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