Quality Systems

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

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

Ask the Expert: Complying with 21 CFR 211.110

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

FDA Warns Sanofi About API CGMP Deviations, Issues Clinical Hold on Atara Immunotherapies

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

Sustainability in Pharmaceutical Manufacturing

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Cavazzoni Retires as CDER Director

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

Using Continuous Processes and Automation to Remove Contamination Risk

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

FDA Publishes Final Guidance on Advanced Manufacturing Technologies

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Gail Reed is senior scientist with Johnson & Johnson.

Yelena Ionova is senior manager, Data Strategy and Analytics with Redica Systems.

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence.  The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

Specification Equivalence—A Practical Approach

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

FDA Creates CDER Center for Real-World Evidence Innovation 

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

Regulatory/GMP Compliance