Quality/GMPs

Articles

Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.

Ensuring Quality When Sourcing Biopharmaceutical Raw Materials 

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

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?

A New View on Quality Control?

 Washington Editor, jillwechsler7@gmail.com.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs. 

Pandemic Alters FDA Inspections and Quality Oversight

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

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits. 

The Remote Audit–A Tongue-in-Cheek Memo

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

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

FDA Under Pressure to Restore “Normal” Drug Inspections

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

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

Audits and Inspections