Quality/GMPs

Articles

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements. 

Consent Decree Against Oklahoma Drug Compounder Enters Federal Court

Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).

Joseph Mongillo works in analytical research and development at Pfizer

Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).

Christian Metz works in Analytical Research and Development at AbbVie Inc., Ludwigshafen, Germany.

Katria Harasewych works in quality at Merck & Co., Inc. (Kenilworth, NJ).

Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

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

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.

Audits and Inspections