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© 2023 MJH Life Sciences and BioPharm International. All rights reserved.
© 2023 MJH Life Sciences™ and BioPharm International. All rights reserved.
December 21, 2022
The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.
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.
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.