Quality/GMPs

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

Articles

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

The Importance of Batch Record Reviews During Audits

 Washington Editor, jillwechsler7@gmail.com.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

FDA Faces Huge Task Catching Up on Inspections

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

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority. 

Quality Still a Priority

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

Ensuring Quality When Sourcing Biopharmaceutical Raw Materials 

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?

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, 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.

Audits and Inspections