Pharmaceutical Engineering® is launching a new series of profiles of industry leaders. This ongoing series will look at the lives and careers of individuals who are changing the face of the pharmaceutical industry.
Ranjana Pathak has spent nearly 40 years in the pharmaceutical industry. Currently the President and Global Head of Quality, Medical affairs, and Pharmacovigilance at Cipla Ltd. in Mumbai, India, Pathak’s long tenure has afforded her an informed perspective on the past, present, and future of the industry.
The pharma industry has its Pharma 4.0TM champion in Christian Wölbeling, an IT expert. Starting with ideas jotted down on a restaurant napkin, he has tirelessly and expertly led ISPE’s global efforts to define the industry’s slow but sure progression toward a holistic strategy to achieve the Pharma 4.0TM goal.
This article takes a historical look at the evolution of facility design, specifically focused on how “flexibility” has advanced to the industry’s current process and possible future states.
The ISPE Pharma 4.0TM Special Interest Group has designed an operating model as a framework for how digitalization can be applied to ICH Q8–Q12 and named it the “holistic control strategy.” This article introduces the strategy and presents two case studies of companies that have started to apply it.
Looking forward, manufacturers should anticipate future format, packaging, and filling needs, and seek technologies with sufficient built-in versatility. This article explores a promising holistic cleanroom concept for high-quality aseptic processing of drugs.