Posts by:
In our USP <797> Q&A Series, we’ve mentioned cleanrooms a few times but haven’t gone too deeply into the topic. As in other areas, the revised USP <797> standard includes a few changes. Some tighten up the requirements, while others leave things open to interpretation. Here are answers to some of the more frequent questions we get on USP <797> cleanroom standards.
In this series of Q&A posts, we’re answering questions from customers about USP <797> compliance. Some of these are common questions. Others, not so much. All are important.
If you have questions about how to comply with the latest revisions to USP <797>, you’re not alone. Even though the standard has been in effect since November of 2023, we’re still getting a lot of foundational questions about specific requirements.
Aspergillus, Bacillus, and Cladosporium – The Importance of Genus Identification
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.
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 ample evidence that these SOPs are followed and effective.
Lately, the Pace® microbiology team has been fielding a lot of questions on how to interpret and implement different aspects of the revised USP <797> standard. Here are some of the most frequently asked questions regarding the use of sampling media kits.
