Quality Systems

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

Articles

Industry should be seeking more information from FDA on how it will restart its current inspection program.

Will FDA Inspections Ever Be the Same?

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines. 

FDA Works to Resume On-site Domestic Inspections

Ajay Pazhayattil is a management consultant. (ajpazha@gmail.com). He has held key management roles with brand name, generic, and contract manufacturing pharmaceutical organizations. 

483s and Warning Letters Point to Inadequate Quality Oversight

Solving Pharma’s Quality Unit Identity Crisis

James P. Stumpff, RPh, is principal consultant with Parexel International, jim.stumpff@parexel.com.

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

Succeeding With OOS and Root-Cause Investigations

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

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Following Guidelines During a Crisis

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.


Complying Confidently? Learning Lessons from Nitrosamine Impurities

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

FDA Continues to Warn Companies Marketing Products to Treat COVID-19

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Critical Knowledge for Preparing Audits

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.


Being Vigilant in Supplier Oversight

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

Audits and Inspections