By Juergen M. Metzger, Pharma-Technology-Consulting, LLC
Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is how it is applied.
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert
This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.
Stop chasing missed pull windows caused by disconnected spreadsheets. Centralized, automated systems ensure regulatory compliance and keep your critical stability studies on track today.
We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.
Modernize sterile manufacturing with robotic fill-finish systems. Achieve multi-format flexibility and risk reduction to meet the rigorous demands of personalized medicine and small-batch production.
