Meeting the Needs of Pharmacies, 503B & CGMP Manufacturers
Meeting the Needs of Pharmacies, 503B & CGMP Manufacturers
Eagle went to its first show in 2024, an enlightened 3-day exploration at the HRT Functional Medicine Symposium in Vegas! Thank you, PCCA, for creating an event to showcase the latest advancements in health and wellness.
We look forward to seeing you!
#HRTVegas2024 #eagleanalytical | PCCA
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 Chapters <795> and <797> and are in effect as of November 1st, 2023. To remain compliant with the new regulations, facilities must understand the changes.
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 irresolvable limitations are statistical and biological. While the attribute “sterile” applies to a complete absence of living organisms (an absolute condition), there is no test that can detect all living organisms, and the complete absence of living organisms could only be tested if the entire production of the preparation were tested (and thus destroyed).
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 were not consistently understood. Most of the revisions involved guidance on stability and sterility considerations for nonsterile and sterile preparations.
Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple-dose products. Antimicrobial effectiveness should be demonstrated for all products containing preservatives including injections and other aqueous-based, multiple–dose products not limited to ophthalmics, topicals, and oral dosage forms.
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!
Event Information | Event Images 1 | Event Images 2
It was an honor to participate as both an exhibitor and educator at this year’s PCCA International Seminar that took place in Woodland, Texas. It was great getting to see so many and we really enjoyed our conversations with you. We eagerly look forward to ISTX24!!
Thank you, Health Connect Partners (HCP), for organizing this worthwhile event! It was our pleasure to be part of #HCP2023 and we hope it was as profitable for everyone as it was for us.
Eagle attended the 2023 PDA Pharmaceutical Microbiology Conference taking place this October 2nd – 4th in Washington DC.
The conference addressed the most relevant opportunities and challenges to the future of microbiology in our global market. Professionals from all facets of the global industry, academia, and regulatory authorities, shared insights on how to best prepare for the future through best practices, development of standards, and integration of innovative technologies.
The event proved to be of great value and we look forward to participating in next year’s conference.
Eagle attended the 2023 PDA/FDA Joint Regulatory Conference in the nation’s capital.
This year’s topic was CGMP: Quality Through Science and Innovation. A lot of great information was discussed, and ideas were exchanged.
We look forward to 2024’s conference and hope to see you there.