Quality by Design

Process Analytical Technology and Process Control in Solid-Dosage Manufacturing

April 02, 2013

Industry is moving toward closed-loop control of continuous processing.

Advancing QbD in the EU

April 02, 2013

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

The Role of Analytical Science in Implementing Quality by Design

March 02, 2013

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.

Relevance Regained

March 02, 2013

Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.

Advances in PAT for Parenteral Drug Manufacturing

March 02, 2013

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Catching Up

March 02, 2013

QbD paradigm advances process understanding in development and manufacturing.

Quality by Design in Excipients

March 01, 2013

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

Standardizing Excipient Information to Achieve Supply-Chain Security

March 01, 2013

The use of various documents and guides by the International Pharmaceutical Excipients Council can facilitate the flow of information among excipient manufacturers, distributors, and users.

Patents and Postapproval Batch Testing

December 02, 2012

Can postapproval FDA filings immunize pharma companies from patent lawsuits?

Nuclear Magnetic Resonance as a Bioprocessing QbD Application

November 01, 2012

The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.