FDA Recommends Manufacturers Hire Process-Drift Watchdogs

Manufacturers need to get in-house experts in statistical tools to monitor unwanted variability in their processes if they don’t already have them, according to Grace McNally, a consumer safety officer in CDER’s Office of Compliance, Division of Manufacturing and Product Quality. Such experts can help drugmakers choose the best tools to monitor products and processes to avoid “process drift,” or undesired process variability. To detect process drift, normal variability for a process must first be understood and measured where possible, McNally said.
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