By Carla Reed, president, New Creed LLC
Chain Strategy Visibilty Map
There is always a lot of discussion and debate related to the challenges faced by companies within the industry broadly described as life sciences. Price pressure for mature pharmaceutical products, shortage of supply for critical vaccines and other life-saving compounds, pipeline management for promising molecules and therapies — the list goes on. There are many proposed approaches to address these challenges, all with a common thread: Adopting a life cycle management approach will assist in identifying risk factors and constraints and provide structure and control, with a clearly defined methodology to identify and mitigate risk.
Pharmaceutical manufacturing is a very structured process, with well-accepted concepts like quality by design (QbD) and chemistry, manufacturing, and controls (CMC) embedded into standard ways of working. However, in a global environment where different manufacturing processes increasingly take place in different physical and geographic locations, there is one more consideration: The supply chain-related processes need to be considered as part of the true product life cycle.