Establishing and maintaining full transparency between industry and regulatory agencies is critical to successful daily operations, product quality, and sustainable supply. Clarifying expectations for all parties through consistentand frequent communication and through complete and accurate documentation facilitates the inspection process and when needed, guides responsesto regulatory actions. Routine follow-up holds no surprises and serves to strengthen the regulatory-industry relationship. The process of improving product quality becomes a shared goal for patient safety and access.
Director, Division of Drug Quality I,
Credits: None available.
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