Quality Systems

Articles

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.

Implications and Opportunities of Applying QbD Principles to Analytical Measurements

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Angie Drakulich was editorial director of Pharmaceutical Technology.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

PAT: A New Dawn for Drug Product Quality

is head of TechOps QA at Novartis in Basel, Switzerland, and a member of the European Federation of Pharmaceutical Industries (ADS) topic team.

is global director of global analytical R&D at Abbott Laboratories in Abbott park, IL, and a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) Analytical Technical Group (ATG).

is vice-president of Analytical Sciences at Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., PO Box 368, Ridgefield, CT 06877-0368, tel. 203.798.5701

Phil Nethercote is a director in New Product Support, Global Manufacturing Supply at GlaxoSmithKline (Ayrshire, UK).

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

Implications and Opportunities of Applying QbD Principles to Analytical Measurement

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi,  Tel. +91.9650770650, asrathore@biotechcmz.com.

References for the article published in the February issue of Pharmaceutical Technology Europe.

Quality by Design for biotechnology products: challenges and solutions &#151; References

The US Food and Drug Administration released a warning to the public on Dec. 29, 2009 about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

FDA Impersonators Threaten Public Safety

The European Public Health Alliance published its comments about the Falsified Medicines Directive currently under debate by the European Parliament and Council.

EPHA Comments on Falsified Medicines Directive

The authors discuss a study that demonstrates the use of polyethylene oxide mixtures to investigate the effect of polymer viscosity on formulation robustness.

Using Polyethyline Oxide Blends to Assess the Effect of Excipient Variability

On Sunday, Nov. 8, 2009, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed its disappointment with the US House of Representatives's healthcare-reform bill.

PhRMA Reacts to House Healthcare-Reform Bill

Robert Lionberger is a chemist at the Office of Generic Drugs at the US Food and Drug Administration.

Gordon Johnston is vice-president of regulatory sciences at the Generic Pharmaceutical Assocation.

Lawrence X. Yu is deputy director for science in the Office of Generic Drugs (OGD) at the US Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855.

Gary Buehler is director of the Office of Generic Drugs at the US Food and Drug Administration.

Michael C. Olson is a chemist at the Office of Pharmaceutical Science at FDA.

Helen Winkle is director of the Office of Pharmaceutical Science.

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Quality by Design for Generic Drugs

FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development.