by Eagle Analytical | Mar 12, 2020 | All Posts, USP
USP Issues a Decision on: 795, 797, and 825 USP has published a notice communicating the final decisions from the Appeals Panel in relation to USP <795>, <797>, and <825>. The chapters which address the compounding of nonsterile (<795>) and...
by Ross A. Caputo Ph.D. | Feb 12, 2020 | All Posts, USP
Environmental Monitoring & Why it Matters: Part 2 Read Previous Article: Environmental Monitoring and Why it Matters – Part 1 The Importance of Trending and Analyzing Data Chapter <797> of the United States Pharmacopeia (USP) outlines the operational...
by Ross A. Caputo Ph.D. | Feb 5, 2020 | All Posts, USP
Avoid Relying on Sterility Tests Alone Sterility tests cannot reliably detect contamination in compounded sterile products (CSPs) because of inherent limitations in testing and sampling methodologies. Nor can the sterilization process be relied upon to eliminate all...
by Eagle Analytical | Dec 3, 2019 | All Posts, USP
On Sunday, December 1st, the USP <800> standards became official. Our consultants can help you ensure compliance with this new chapter. Learn more about our consulting services and contact us today at 800-745-8916.
by Eagle Analytical | Apr 18, 2019 | All Posts, USP
On July 27, 2018, the Compounding Expert Committee of the United States Pharmacopeia (USP) published proposed revisions to USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations. The proposed chapter was open to public comments until November 30,...
by Eagle Analytical | Apr 5, 2019 | All Posts, FDA, USP
In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England Compounding Center, Congress passed the Drug Quality and Security Act, which amended the federal Food, Drug, and Cosmetic (FD&C) Act and more clearly defined the FDA’s...
