Quality Systems

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Articles

Will biosimilars share a compendial identity like generic drugs do?

What’s In a Name? For Biosimilars, A Lot

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

The directorate highlights achievements accomplished during the year of its 50th anniversary.

EDQM Releases 2014 Annual Report

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

ACHEMA Presents BioBasedWorld, Process Analytical Technology, and Industrial Water Management

The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

QbD and PAT: A Marriage Made in Heaven?

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Ensuring the Quality of Biologicals

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

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

FDA Revises Field Inspections to Reflect Global Market and Quality Initiatives

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

Modernizing Scale-Up

Agnes Shanley is senior editor of Pharmaceutical Technology.

QbD represents a breakthrough in thinking, but does it go far enough to address today's business challenges? NeoStem has expanded it to include business and market issues, in "Development by Design." Could this be (or is it becoming) a new model for pharma?

Is It Time to Ditch QbD for Development by Design? Questions From a QbD Cheerleader

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

CDER and Biotech Quality Assessment

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.

Quality by Design