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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
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.
Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
August 20, 2021
ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.
August 01, 2021
Congress questions FDA on plans to catch up and move forward with facility inspections as pandemic travel restrictions ease.
July 30, 2021
Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.