Quality/GMPs

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

Articles

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel. 

Best Practices for Developing a Third-Party Auditing SOP

 Washington Editor, jillwechsler7@gmail.com.

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

FDA Confirms Ongoing Reliance on Remote Inspection Methods FDA Confirms Ongoing Reliance on Remote Inspection Methods 

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

FDA Advances Quality Initiatives to Combat Drug Shortages 

FDA will use virtual site visits even after resuming active inspections.

FDA to Continue Inspection Efficiencies After Pandemic

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

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

Meg Rivers is the former senior editor for 

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. 

Audits and Inspections