November/ December2009
Volume 29, Number 6
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 © 2009 ISPE. All rights reserved.)
Articles
Commissioning, Qualification, and Verification – Lean Approach to Implementation
by Ms. Sabra Seyer, Dr. Graham Wrigley, Mr. Gert Moelgaard, Mr. Nicholas Andreopoulos
This article describes the approach for implementation of the ASTM E2500 standard in Pfizer to enable a cost-efficient and lean approach to science- and risk-based verification.
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Applying Quality Risk Management Principles to Achieve a Practical Verification Strategy
by Mr. Ian Campbell
This article presents a practical application of Quality Risk Management for the extent of verification necessary during Factory Acceptance Testing (FAT), Commissioning and Qualification (C&Q).
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Pharmaceutical Manufacturing: How to Understand the Process and Assess the Risks to Patient Safety
by Robert Jones
This article reviews the latest FDA philosophy to enhance and modernize the regulation of pharmaceutical manufacturing and product quality, which is perhaps best captured in two mottos: “Know Thy Process” and “Know Thy Risk.”
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Industry Interview Series: Jon Clark, Associate Director for Policy, CDER Office of Pharmaceutical Science (OPS), FDA, and Cliff Campbell, CEO, Campbell Informatics
by Mr. Jon Clark, Mr. Cliff Campbell
Jon Clark and Cliff Campbell discuss the findings of a project to determine a regulatory approach for a firm to change the manufacturing site for sterile drug products without requiring manufacturing data before approval.
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Good Weighing Practices for the Pharmaceutical Industry – Risk-Based Qualification and Life Cycle Management of Weighing Systems
by Dr. Klaus Fritsch
This article presents a universal method to select and test weighing instruments based on an integrated qualification approach. Considering primarily the user's weighing requirements and risks, it describes a state-of-the-art strategy to ensure reliable weighing processes embedded in any current quality management system.
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Construction Quality: the Key to Successful Capital Projects Delivery
by Mr. Jay Lad, Dr. Bruce Beck
This article discusses why Construction Quality Management (CQM) is the key to delivering successful capital projects and outlines some of the challenges encountered from a construction/field execution perspective, rather than design/engineering perspective. It highlights the pivotal role of CQM in ensuring that a facility has good operability and availability as well as high reliability and maintainability.
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Departments
Global Regulatory News
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ISPE Update
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Classified Advertising with Advertiser’s Index
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Online Exclusive Articles
Case Study: Risk-Based Approach to Containment and Control for Potent/Hazardous Compounds
by Hisao Takahashi, Mr. Shigehito Nakamura
This case study reviews an approach to containment and control and provides practical countermeasures to prevent cross-contamination from potent or hazardous compounds in pharmaceutical integrated manufacturing facilities.
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Industry Meets Regulators for PQLI Update in Strasbourg
by Dr. Kate McCormick
This article presents the key messages from the presentations and conclusions from the PQLI workshops held in Strasbourg in September.
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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 © 2009 ISPE. All rights reserved.)
