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February 02, 2022
The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.
Toxicology studies are an important and required aspect of drug development that are performed to ensure that drugs are deemed safe prior to patient administration and use in clinical trials.
January 03, 2022
Workforce training is crucial for biopharmaceutical manufacturing.
January 02, 2022
Continued process verification for a cleaning validation program begins once the validation study is complete.
Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.
December 10, 2021
Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.
December 03, 2021
While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.
December 02, 2021
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
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.