FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
|Articles|February 1, 2022
AQbD Method Development: Reduce Out-of-Specification Results and Gain Regulatory Confidence
Author(s)Waters
See how implementing an enhanced approach, like Analytical Quality by Design (AQbD), for method development can help you to access high quality, reportable data.
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