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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
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 02, 2022
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
June 02, 2022
FDA will use virtual site visits even after resuming active inspections.
April 12, 2022
Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.
March 15, 2022
This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.
March 02, 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 02, 2022
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
November 02, 2021
An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.