Consultant would help FDA’s CMC reviewers on QbD, PAT and regulatory strategy
This article was originally published in The Gold Sheet
FDA's Office of Pharmaceutical Science on April 12 said it plans to retain a consultant to help with strategic planning and drug quality training. The planning involves ensuring that regulatory strategies vary appropriately depending on manufacturers' understanding of their manufacturing processes, process controls and quality systems. The chemistry, manufacturing and controls reviewer training will focus on quality by design and process analytical technology
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