Case Study - Roche Carolina Sets the Standard for Quality Control
Client
The Roche Carolina campus makes and develops manufacturing processes for active pharmaceutical ingredients (APIs) and intermediate compounds. A division of Roche, with global headquarters in Basel, Switzerland, the facility makes the active ingredients for Xeloda® for breast/colorectal cancer, Xenical® for obesity, Tamiflu® for the flu virus and Pegasys® for hepatitis C. The South Carolina campus includes one of the company’s Pharma Tech Centers, a research and process development center that includes a pilot–scale production plant.
Challenge
Meet or exceed regulatory requirements and release product as quickly as possible.
Solution
Lab associates implement 5S principles, sorting material and equipment, setting everything in order by storing it in common and highly visible locations, standardizing labels and driving sustainability with daily, weekly and monthly checklists.
Results
QC labs achieved zero observations following their most recent FDA audit. The inspectors even used the laboratories 5S processes to train their staff in best manufacturing practices. From a customer point of view, testing lead times remains constant at industry-leading levels of less than five days, despite a five-fold increase in output for critical drugs.
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