Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
The Appropriateness of the ScanRDI® Sterility Testing Method
Introduction Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices…
Oct, Tue, 2023
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…
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…
Oct, Thu, 2023
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…
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…
Sep, Thu, 2023
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)…
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)…
Jul, Tue, 2023
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…
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…
Jun, Wed, 2023
Water Activity | USP 795 & 797 Revisions
The new practice of using water activity as a tool for establishing the BUD of a CNSP is described…
Water Activity | USP 795 & 797 Revisions
The new practice of using water activity as a tool for establishing the BUD of a CNSP is described…
May, Tue, 2023
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Cleanroom Certification | USP 795 & 797 Revisions
A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six…
Mar, Thu, 2023
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Surface Wipe Sampling Technique
In the following video, we demonstrate how to correctly conduct surface wipe sampling using Eagle’s SurfaceShield kit for the…
Mar, Thu, 2020
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>,…
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>,…
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.
Environmental Monitoring & Why it Matters: Part 3
Data collected from an environmental monitoring program for compounding facilities are often analyzed using less sensitive metrics. Compounders often focus on whether the number of CFUs recovered per plate falls below the limits outlined in USP <797>.
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 2
In this article, Dr. Ross Caputo outlines the importance of trending and analyzing data from an environmental monitoring program in order to provide critical indicators about the state of control of the sterile compounding environment.
Environmental Monitoring & Why it Matters: Part 2
In this article, Dr. Ross Caputo outlines the importance of trending and analyzing data from an environmental monitoring program in order to provide critical indicators about the state of control of the sterile compounding environment.
Feb, Wed, 2020
Environmental Monitoring & Why it Matters: Part 1
Environmental monitoring is an important element of the quality assurance program at sterile compounding facilities. Sterility tests cannot reliably detect contamination in compounded sterile products
Environmental Monitoring & Why it Matters: Part 1
Environmental monitoring is an important element of the quality assurance program at sterile compounding facilities. Sterility tests cannot reliably detect contamination in compounded sterile products
Dec, Tue, 2019
USP <800> is Now Official
On Sunday, December 1st, the USP <800> standards became official. Our consultants can help you ensure compliance with this…
USP <800> is Now Official
On Sunday, December 1st, the USP <800> standards became official. Our consultants can help you ensure compliance with this…
Apr, Thu, 2019
A Summary of Proposed Changes to USP 797
Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate.
A Summary of Proposed Changes to USP 797
Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate.
Apr, Fri, 2019
Insanitary Conditions in Compounding Pharmacies: The Regulatory Framework
In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England Compounding Center, Congress…
Insanitary Conditions in Compounding Pharmacies: The Regulatory Framework
In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England Compounding Center, Congress…
Dec, Tue, 2018
The Compounder’s Crash Course to FDA and 503A Exemption Audits
The Compounder’s Crash Course to FDA and 503A Exemption Audits Hosted by Eagle Analytical Services If your pharmacy were inspected by the FDA, would you be prepared?
The Compounder’s Crash Course to FDA and 503A Exemption Audits
The Compounder’s Crash Course to FDA and 503A Exemption Audits Hosted by Eagle Analytical Services If your pharmacy were inspected by the FDA, would you be prepared?
Dec, Tue, 2018
What to Test – When to Test – Why to Test
Join Eagle CEO, Dr. Ross Caputo as he shares the testing requirements for your compounding facility: helping you navigate the “what, when & the why’s” of testing.
What to Test – When to Test – Why to Test
Join Eagle CEO, Dr. Ross Caputo as he shares the testing requirements for your compounding facility: helping you navigate the “what, when & the why’s” of testing.