BioSciences Quality Testing Forum
Spotlight:
Bacterial Endotoxins Test - Case Study
The bacterial endotoxins test (BET) and the limulus amebocyte lysate (LAL) test are mandatory quality control (QC) release tests for injectable drug products. Guidelines for the BET and monographs with endotoxin limits are included in major pharmacopeias.
Today, the US FDA recommends that Process Analytical Technology (PAT) be implemented as part of pharmaceutical manufacturing, which involves risk-based management at every step of the process. More companies are implementing in-line, on-line or at-line tools to provide them with real-time analysis on the manufacturing floor to build quality into process.
A Six Sigma analysis was conducted by an objective third party consultant to analyze LAL test efficiency at a biotech company. The study analyzed the sample process flow and turnaround time for two sets of in-process buffer samples.
BioSciences Quality Testing Forum
Forum on Analytical tools and applications that provide information on the quality of the products and processes to R&D, Quality, and Manufacturing professionals in the BioPharmaceutical and Cosmetics, Personal Care industries.
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