Quality/GMPs

Articles

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.

ICMRA Sets Out Recommendations on Regulation of Future Therapies Using AI

Congress questions FDA on plans to catch up and move forward with facility inspections as pandemic travel restrictions ease.

FDA Inspections Back on Track?

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing

 Washington Editor, jillwechsler7@gmail.com.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

FDA Under Pressure to Restore “Normal” Drug Inspections

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

The Value of FDA 483s and Warning Letters

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

Ensuring Contract Manufacturing Facilities Are Up to Speed

Preparation is key for remote vendor and contract partner audits.

Succeeding with Remote Audits

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. 

FDA Inspection “Roadmap” Acknowledges Continued Delays and Challenges Ahead 

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

FDA on Inspections During and After Pandemic

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Audits and Inspections