Quality Systems

Articles

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products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

Enhancing Quality Through Training

Gary Ritchie, InfraTrac gritchie@infratrac.com, is director of Scientific Affairs at InfraTrac.

Sharon Flank, PhD, sflank@infratrac.com, is CEO at InfraTrac.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

FDA Releases Guidance on Accelerated Approvals

Feliza Mirasol is the science editor for 

EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

Exosomes Field Advances with Milestones Achieved by EXO Biologics and ExoXpert

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

Aloka Srinivasan, PhD, is Principal and Managing Partner, Raaha LLC.

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

Regulatory/GMP Compliance