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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
April 03, 2022
Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.
December 02, 2021
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.
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.
June 14, 2021
Automated systems help detect and resolve quality issues.
May 03, 2021
Applying a QbD approach helps address excipient variability and other quality features.
April 03, 2021
Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.
April 02, 2021
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
March 03, 2021
Integrated, paperless data systems can improve efficiency and quality.
The need for real-time monitoring and control has spurred the development of new analytical tools.