OR WAIT null SECS
© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
May 12, 2021
FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.
May 10, 2021
The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.
May 01, 2021
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
April 21, 2021
A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.
April 20, 2021
FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.
April 16, 2021
The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.
April 09, 2021
Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.
April 01, 2021
Scrutiny of the vulnerability in the biopharmaceutical supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.
March 01, 2021
Auditing distribution suppliers provides understanding and documentation of the services performed.
February 10, 2021
Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.