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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
January 02, 2022
Continued process verification for a cleaning validation program begins once the validation study is complete.
December 17, 2021
Genezen has opened its new process development and analytical lab for viral vector production.
December 01, 2021
Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.
November 02, 2021
Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.
October 03, 2021
Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.
July 02, 2021
A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
December 01, 2020
A holistic approach to validation and quality assurance is essential.
October 16, 2020
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.
August 03, 2020
Regulatory, analytical, and process concerns must be taken into account.