ABSTRACT
This conclusion presents some closing thoughts on the key concepts discussed in the preceding chapters of this book. The book affirms that there is a renewed effort within the industry to lower the cost of goods and reduce inventory levels by enhancing the efficiency, agility, and velocity across the complex and fragmented supply chain. It explores the importance and the role of managing the free flow of knowledge, in a variety of complex environments, to overcome these challenges in a manner that ultimately benefits the patients and stakeholders of the company, including employees and shareholders. Roche showed how critical process parameters (CPPs) and critical to quality attributes (CQAs) can be defined from the manufacturing history available for a legacy product, and then how they can be combined with formal knowledge-based risk assessments to derive significant improvements in the field control strategy. Post-approval surveillance presents a real challenge to the four-pillar framework.
