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December 02, 2022
The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.
December 01, 2022
Health crises, political tension, and budget concerns were major challenges.
November 15, 2022
The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
November 01, 2022
Industry experts discuss best practices for certificates of analysis.
Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.
October 12, 2022
CBER maps modernization plan to handle surge in research and applications.
October 01, 2022
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.
September 15, 2022
Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.
September 01, 2022
A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.
July 20, 2022
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.