Quality Systems

Kalah Auchincloss, senior vice-president and deputy general counsel, Greenleaf Health, Inc.

Articles

This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.

FDA Inspections During COVID-19: A Brave New World

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

FDA Inspectors Cited Critical Problems at Emergent Facility

Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities. 

Pressure Mounts for FDA to Ramp Up Drug Inspections

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

Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.  

Auditing for Good Distribution Practices

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

Florida Manufacturer Warned for Inadequate Written Procedures 

FDA puts applications on hold as the agency limits alternative oversight methods. 

FDA Inspection Shutdown Increasingly Delays Approvals

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Steven J. Lynn is executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.

Frequently Asked Questions on Regulatory Inspections

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

Conducting Effective Audits During and Post Pandemic

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.

Now is the Time to Update the Quality Technical Agreement

Customceutical Compounding was sent a warning letter by FDA after investigators found deficiencies in the production of sterile drug products.

Audits and Inspections