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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Naheed Sayeed-Desta is manager of process validation at Apotex, Inc.
August 01, 2018
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
August 02, 2017
Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.