March / April 2015

March / April 2015 Cover


Drug Shortages and the Quality Debate

by Carol Winfield and John Berridge

Guest Editorial: Metrics that Give Voice to Quality

by Joseph Famulare

Conference Attracts 250 Enthusiastic Participants from Across Industry

From the East To the West

by Shigeru Nakamura and Michael J. Lucey

The FDA Observation Response: Seven Common Mistakes

by Carol Brandt. Seven common mistakes are identified when responding to FDA inspection observations. This article presents examples of regulated-industry responses that may not meet the FDA requirements for a thorough response.

Using Process Capability To Ensure Pharmaceutical Product Quality

by Lawrence X. Yu, Daniel Y. Peng, Robert Lionberger, Alex Viehmann and Karthik Iyer. This article introduces the definition and calculation of process capability, illustrates their use in the pharmaceutical industry, and describes the relationship of process capability with production batch failure rate. The use of process capability in product development, process scale up and qualification, and commercial production is also described.

Pharmaceutical Industry White Paper: Implementation and Application of Quality by Design

by Roger Nosal (Lead Author), Dan Bollinger, Andrew Chang, Xavier Castell, Graham Cook, Frank Diana, Jeff Ferguson, Georges France, Betsy Fritschel, John Groskoph, Nirdosh Jagota, Bob Kelly, John Lepore, Rick Lit, Stephen Mason, Moheb Nasr, Ken Oh, Mark Rosolowsky, Tom Schultz, Steve Tyler, Jim Webb and Diane Zezza. This white paper describes the current status on implementation of Quality by Design (QbD) and recommends options to improve implementation and reconcile different perspectives regarding the application of QbD in regulatory submissions.

HEPA Filters, Unsung Heroes, Ushered In ‘Brave New World’ Of Clean

by Randolph Fillmore. HEPA filters, developed in the 1950s and 1960s for use in the early US aerospace program, enabled current practices in cleanroom technology and pharmaceutical manufacturing.

Tests on Rouging and Experiences Dealing with Rouging in Pharmaceutical Production (Part 1 of 3)

by Thomas Blitz, Ernst Felber, Robert Haas, Birgit Lorsbach, Andreas Marjoram, Roland Merkofer, Tobias Mueller, Nathalie Schuleit, Marc Vernier and Thomas Wellauer
Part 1 of this article discusses the current body of knowledge on the subject of rouging. It is based on insights from tests and operating experiences of companies that manufacture pharmaceutical medicinal products.

Corrosion of AISI 316L in Ultrahigh-Purity Water: Surface Analyses and Metal Release

by Elena Bernardi, Maria Chiara Bignozzi, Cristina Chiavari, Nicola Gandolfi, Carla Martini, Alice Mattei and Salvatore Silvio Sessa
The article presents a study on the corrosion behavior of AISI 316L in pharmaceutical environments over a three-week period. Results showed higher iron release and corrosion current density in distilled water.

A Computer Data Integrity Compliance Model

by Orlando López. This article presents a model that describes the required Annex 11 data integrity provisions applicable to new computer system implementations, and that can be used to assess computer systems in operation.

A Risk-Based Approach to Audit Trails

by Randy Perez, Chris Reid and Sion Wyn. This article addresses the topic of audit trail review, by exploring pragmatic approaches to meeting requirements, while balancing efforts with benefits in terms of safeguarding patient safety, product quality, and regulated data integrity.