OR WAIT null SECS
January 05, 2022
Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.
Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.
Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.
January 02, 2022
Continued process verification for a cleaning validation program begins once the validation study is complete.
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.
December 03, 2021
The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.
December 02, 2021
Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.
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.
December 01, 2021
Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.