Quick Response Manufacturing: Taking The Pharmaceutical Industry Beyond Lean Six Sigma

By Ananth Krishnamurthy and Gerald Finken

Pharmaceutical and biotech industries are under enormous pressure to improve quality, increase efficiency, and cut costs of their preclinical research and clinical development processes. However, the manufacturing of APIs and investigational medicinal products (IMPs) and the preparation of clinical supplies in the pharmaceutical and biotech industries present significant challenges in terms of finalizing the process designs, establishing and maintaining cGMP to meet FDA regulations, and optimizing processes for commercial scale production.

Used with permission from Life Science Leader magazine.