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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
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.
July 07, 2020
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.
July 02, 2020
The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
June 30, 2020
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
May 15, 2020
Ensuring the quality of data in process monitoring and control systems starts in process development phases.