Volume 29, Number 6

Table of Contents

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.

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). 

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.”

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.

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.

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.

Departments

Global Regulatory News

ISPE Update

Classified Advertising with Advertiser’s Index

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