Low Endotoxin Recovery: An FDA Perspective
Posted on April 10, 2015
By: Patricia F. Hughes, Ph.D.,Team Leader in FDA/CDER in the Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Colleen Thomas, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Kalavati Suvarna, Ph.D.,Senior Clinical Microbiology Reviewer in the Office of Antimicrobial Products within the FDA/CDER’s Office of New Drugs.
Bo Chi, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Reyes Candau-Chacon, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Candace Gomez-Broughton, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Lakshmi Rani Narasimhan, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
FDA
Abstract The Code of Federal Regulations, 21 CFR 211.167(a), requires that any drug product claiming to be sterile and non-pyrogenic be tested for conformance for sterility and endotoxin. In addition, 21 CFR 610.13(b) requires that any biological product intended for use by injection be tested for p...
To read the full article and other articles in this issue, please register for a free account or log in.
We will not sell or give your information to a third party. See our Privacy Policy
Related Topics and Keywords
21 CFR 211.167(a), 21 CFR 610.13(b), assessing conformance, Bo Chi, Candace Gomez-Broughton, CFR pyrogen testing requirements, Colleen Thomas, conformance for sterility and endotoxin, FDA Perspective, Federal Regulations, Kalavati Suvarna, Lakshmi Rani Narasimhan, Low Endotoxin Recovery, microbiology, Patricia F. Hughes, Reyes Candau-Chacon, sterile and non-pyrogenic, tested for pyrogenic substances
Related Product Videos
Steritest Symbio Pump - Merck Millipore
Endosafe®-PTS™ - Charles River
Related Products
The new SteritestTM Symbio Pump: Experience easier sterility testing than ever before - Merck MilliporeResolving an Analytical Issue - Demasking of Endotoxin with Endo-RS® - hyglos
Endosafe®-PTS™ - Charles River
Lonza’s QC Testing Solutions
Subscribe to our FREE newsletter and WEBINAR UPDATES
We will not sell or give your information to a third party. See our Privacy Policy
