This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory
"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importa
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Pac
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, W