Case Study: MedImmune’s Frederick Manufacturing Center (FMC) Expansion, Overall Winner, 2011 Facility of the Year Awards
by Rochelle Runas
This article presents the story of how MedImmune used ordinary tools in extraordinary ways to build the MedImmune Frederick Manufacturing Center Expansion, Overall Winner of the 2011 Facility of the Year Awards. 

Alternative Software Development Models and Methods in GxP Environments
by Members of the ISPE GAMP D-A-C-H SIG ASDMM
This article presents methods used for the development of all types of software, from infrastructure software to bespoke applications.

Risk Analysis and Mitigation Matrix (RAMM) – A Risk Tool for Quality Management
by Alex Brindle, Steve Davy, David Tiffany, and Chris Watts
This article presents a new type of risk tool. Risk Analysis and Mitigation Matrix (RAMM) was developed to be incorporated into a modern risk management system and align with latest FDA guidances.

Reducing Variability and Out-of-Specification Results by Implementing High Quality Gravimetric Sample Preparation (GSP)
by Klaus Fritsch, Joanne Ratcliff, and Charles Ray
This article presents the current limitations of outdated sample preparation workflows in analytical R&D and QA/QC laboratories and introduces new approaches to improving quality and reducing variability, errors, and Out-of-Specification (OOS) results.

A Quality Risk Management Approach to Review and Monitor Cleaning Processes
by Ian Campbell and Dominic Thibeault
This article presents a risk-based approach to continuous quality verification of cleaning procedures.

Industry Interview Series: Mary Oates, Vice President of Global Quality Operations, Pfizer
by Cathy Middelberg and Jeff Hargroves
Pfizer’s Vice President of Global Quality Operations discusses the elements and challenges of quality risk management. She provides insight into how Pfizer applies risk management to product quality decisions.