Quality Systems

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

Articles

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

The Inspection Result: Warning Letters and Form 483s

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.

Write it Down, Investigate, and Control

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

Alasdair Leckie is operations director at Rephine Ltd, a firm of deeply experienced GMP auditors which proactively help pharmaceutical companies around the world with their supply-chain quality assurance. Alasdair has been with Rephine for nine years and has a Bachelor’s Degree in Chinese and Economics from SOAS University of London.

A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients. 

Will Remote Pharma GMP Auditing Endure Post-Pandemic?

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

Jill Wechsler is Pharmaceutical Technology's 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 

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

Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.

The Role of Technology in CAPAs

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

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

Audits and Inspections