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The FDA draft guidance Considerations for Complying with 21 CFR 211.110 raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies. "When continuous process verification is used, the continuous manufacturing system performance and output material quality [should be] continuously monitored, such that the real-time data collected demonstrate the maintenance of a state of control and production of output material with the desired quality for the runtime duration," Pund wrote in the comment to FDA (6). Simulated data derived from rigorous models ... ensures that multivariate process models maintain control over manufacturing operations using the aforementioned statistical methods."