The principles of quality by design (QbD) and life cycle management, as outlined in International Council for Harmonisation (ICH) Q8–Q12, can equally be applied to the development, validation, and ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

WOKING, United Kingdom, May 2, 2023 /PRNewswire/ -- IDBS is pleased to reveal new process definition-handling enhancements in its latest release, PIMS 5.0. Providing contextualized access to ...

The Medical Validation Procedure is very critical to verify that the system offers repeatability, assurance of accuracy, and a high degree of quality, according to a release from MTMS. The company ...

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX. Among a list of top ...

Escherichia coli (E. coli) has been commonly used for the production of biopharmaceuticals. Among the impurities that must be monitored in biopharmaceuticals is residual host-cell DNA (HCD). This ...