March/April 2014

Volume 34, Number 2

Quality systems is the focus of two articles in the March/April issue. The first provides ways to implement an effective quality management system to allow manufacturers to meet their ethical and regulatory obligations. The second presents a consistent, compliant and practical risk-based validation process for laboratory systems. Other topics in the issue include blend and content uniformity in an article summarizing the stratified sampling session held at the 2013 ISPE Annual Meeting, the importance of a Project Execution Plan (PEP) for a pharmaceutical facilities project, good construction practices for work in existing pharmaceutical facilities, interactions between the ASME Bioprocessing Equipment (BPE) Standard and ASME B31.3 Process Piping Code Committees basic concepts and principles of clean design, and how an integrated TOC monitoring system can increase productivity, help meet PAT and QbD goals, and provide ongoing assurance over the life cycle of the process.

 

NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2014 ISPE. All rights reserved.)


 

Quality Systems

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.
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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.
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Product Development

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.
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Facilities and Equipment

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.
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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.
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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.
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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.
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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.
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President's Message

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.
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Also Inside

From the Editor
by Gloria Hall, Editor, Pharmaceutical Engineering

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ISPE Update
New Quality Culture Drives the Comeback of Pharmaceutical Engineering; Health and Human Services Releases its Semiannual Regulatory Agenda; Janet Woodcock Includes ISPE in FDA Statement to Congress; Background of Quality Metrics; Excitement Builds for 2014 Facility of the Year Awards; Japan Affiliate “On the Road” Again
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Classified Advertising with Advertiser’s Index

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Online Exclusives

Global Regulatory News

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NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2014 ISPE. All rights reserved.)