Pharma Pursues Generic Injectables Quality Turnaround Opportunities
This article was originally published in The Gold Sheet
Pfizer’s plan to acquire Hospira is part of a turnaround trend in which Big Pharma hopes its quality will rub off on the troubled generics injectables sector. The question is: Will it work?
You may also be interested in...
After years of Mylan’s “one quality standard,” the merger with Pfizer Upjohn brings another. Which will prevail? Which should prevail?
A more effective approach to quality assurance could result from an operational pause at a Pfizer plant in India, where the company is responding to US FDA inspectional observations of poor data integrity and inadequate investigations that are expected to result in a warning letter.
US FDA's inspection found a major problem in the operations of the facility that became Baxter’s when it acquired Claris: staff were blaming the laboratory for out-of-specification test results when they should have been fixing the manufacturing process. The result: a warning letter packed with assignments for the new owners.