Moving from Quality Control to Quality Assurance
by Guy Wingate, PhD
This article provides ways to implement an effective quality management system to allow manufacturers to meet their ethical and regulatory obligations.

Applying a Consistent, Compliant, and Practical Risk-Based Validation Process for Laboratory Systems
by Anil K. Rattan, PhD and Michael Rubacha
This article presents a consistent, compliant and practical risk-based validation process for laboratory systems.

Current Events in Blend and Content Uniformity
by James S. Bergum, PhD, James K. Prescott, Ravindra W. Tejwani, Thomas P. Garcia, PhD, Jon Clark, and William Brown
This article presents a summary of the stratified sampling session held at the 2013 ISPE Annual Meeting.

Project Execution Planning: The Key to Successful Pharmaceutical Project Delivery
by Robert Garner
This article presents the importance of a Project Execution Plan (PEP) for a pharmaceutical facilities project, outlines the fundamental aspects of a PEP, and details what should be included in each section.

Construction Practices: Contamination Risk Reduction within Ongoing Operations
by Charles Hammond and Steve W. Van Wormer
This article presents good construction practices for work in existing pharmaceutical facilities and encourages further development of construction procedures to prevent product safety issues.

High Purity Process Piping: Harmonization of ASME Codes and Standards
by Barbara Henon, Vince Molina, Richard Campbell, and William Huitt
This article presents interactions between the ASME Bioprocessing Equipment (BPE) Standard and ASME B31.3 Process Piping Code Committees following the addition of Chapter X High Purity Piping to the 2010 Edition of B31.3. This collaboration of ASME Committees will help to assure both safety and cleanability of high purity piping systems.

The Dirt on Cleaning and Sanitization
by Neil Lewis and Steve Shank
This article presents an overview of the basic concepts and principles of clean design which should be applied when considering equipment and system design.

On-Line TOC Monitoring in GMP Parts Washers
by Marcel Dion, Olivier Van Houtte, and George Verghese
This article presents a TOC monitoring system integrated into a parts washer and discusses how it can increase productivity, help meet PAT and QbD goals, and provide ongoing assurance over the life cycle of the process.

Spanning the Globe and Making a Difference
by Nancy Berg, ISPE President/CEO
Berg discusses how ISPE is stimulating new approaches, leading change in how business is conducted and influencing how regulations are being developed through global regulatory interaction.