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The Center for Biologics Evaluation Keeps Biological Product Standards High

A laboratory quality management system is key

Peter Marks
Thu, 03/03/2016 - 12:26
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Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the center as the preeminent regulatory organization for biologics. One way CBER is achieving this is through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines Research and Review (OVRR).

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These offices play a major role in helping to ensure the safety and quality of products regulated by CBER. Their work shows that CBER isn’t just talking the talk about its vision, it’s also walking the walk to demonstrate the expertise needed to fulfill it.

That walk leads directly to OCBQ’s Division of Biological Standards and Quality Control (DBSQC), OVRR’s Laboratory of Immunobiochemistry (LIB), and the center’s Laboratory Quality System (LQS) Program.

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