Everyone expects medicines to be safe and effective. Therefore, regulatory authorities require that drug manufacturing processes follow current Good Manufacturing Practice (cGMP). Microbiological testing commonly occurs at several stages of drug development to ensure that products are not contaminated by pathogens.
cGMP regulations require systematic documentation of each step within every manufacturing protocol as well as a full audit trail. This precise documentation is necessary to certify that each regulated product on the market has passed the required quality testing. In order to complete the requested documentation, analysts need to interrupt their experiment after each step to sign a form and report the exact time of completion. Moreover, some sensitive steps such as calculations must be validated by a Quality Assurance manager following the four eyes principle. Documenting microbiological testing for cGMP compliance often doubles the time of an experiment.
Whether it is to reduce the considerable costs of drug development or to respond urgently to a pandemic, shortening the time of product development to market delivery is an indisputable goal for this decade. Such a revolution will come from the digitalization and automatization of key processes, thus supporting the scientists who work in GLP and cGMP environments.
LabTwin provides a unique and powerful solution by allowing voice-guided documentation with automatic audit trail at the point of experimentation.
In this report, we review the challenges and requirements of documentation in cGMP environments using three classic microbiology tests (the Endotoxin Test, the Agar Overlay Test and Serum Bactericidal Assay) as examples. We show how LabTwin helps scientists overcome these challenges by fully supporting cGMP regulations and ALCOA+ principles.
This is exactly how I thought LabTwin and LabTwin's protocols would work!
Scientist Quality Operations, Top 10 Pharma
Download this report today to find out how can cGMP and QC analysts make use of the world’s first AI and voice-powered digital lab assistant to document microbiological testing and reduce their documentation time by up to 50%.