We have located links that may give you full text access.
Quality Control and Basics of Sterile Compounding: Attempting to Avoid Out-of-Specification Results and Patient Harm in Sterile Compounding.
International Journal of Pharmaceutical Compounding 2019 January
What do you do when something goes wrong in your cleanroom? What do you do when a sterility test fails and what are the implications of such a failure? What should you do when your environmental monitoring or personnel monitoring provides results that exceed your action levels? A root cause analysis is needed in any situation where action levels are exceeded or tests are out of specification. However, should the questions be what can be done to prevent these occurrences, and how can the development be noticed before they occur? In this article, we will discuss going beyond the recommendations of United States Pharmacopeia Chapter <797> to attempt to build a program that limits the possibility of contamination through monitoring of the facility, personnel, and procedures in aseptic processing. We will also discuss other resources published by the U.S. Food and Drug Administration that address monitoring of sterile compounding and aseptic processing.
Full text links
Related Resources
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app