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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
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.
August 02, 2022
FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.
July 01, 2022
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
June 01, 2022
FDA will use virtual site visits even after resuming active inspections.
March 01, 2022
Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.
February 08, 2022
With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.
January 01, 2022
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
December 02, 2021
Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.
November 02, 2021
COVID-19 created challenges for quality control departments. How have the lessons learned from the pandemic influenced the way companies use technology to perform quality-control procedures?
November 01, 2021
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.