Volume 27, Number 2

Table of Contents

Articles

Eight Steps to PAT: Using the Design for Lean Six Sigma Toll-Gate Process as Best Practice

by Bikash Chatterjee, Jeremy Green
This article outlines an eight-step six Sigma toll-gate approach to PAT implementation.

Lean Data Analysis: Simplifying the Analysis and Presentation of Data for Manufacturing Process Improvement

by Malcolm Moore
This article introduces a data analysis maturity model that maps various tools and methodologies aimed at predicting, analyzing, improving, or controlling the drivers of product quality to the extent to which these techniques may help reduce defects. By mapping tools currently deployed in a particular manufacturing facility to the maturity model, it is possible to define a cost-effective road map for various initiatives aimed at improving product quality through increased process understanding. Pragmatic data analysis and reporting approaches are introduced to aid process understanding for mainstream users and the deployment of that understanding in manufacturing to increase product performance.

Introduction to Real Time Process Determination

by Kim Walter
This article introduces a state-of-the-art method to track conditions for wet processes that provides continuous operating guidance through a combination of measured and calculated values.

Cost and Benefit Analysis of Validation Strategies

by Kent Lohrey
This article evaluates the time (labor effort) required to validate computer or software systems as a function of the applied validation strategy.

Industry Interview Series: Richard S. Overton, Vice President of Operations and Facilities, Forest Laboratories

This once aspiring professional basketball player talks about his unconventional career path into the pharmaceutical industry and Forest Laboratories; his experience running company operations and facilities in different parts of the globe; his thoughts on Quality by Design; the therapeutic areas to watch; and the major industry challenges ahead.

The Use of Exponentially Weighted Process Statistics (EWPS) and Statistical Process Control (SPC) in High Frequency Data Acquisition of Pharmaceutical Water Systems Instrumentation

by Nissan Cohen
The article presents high frequency data acquisition in continuous pharmaceutical processes and illustrates, through the use of EWPS, the need for process understanding, control, and improvement.

Unified Manufacturing Control System (MCS) Architecture for Pharmaceutical and Biotech Manufacturing

by Ronald E. Men, Darrell Tanner
This article reports on a unified MCS architecture using commercially available MES and PCS. It explains the steps in moving beyond paperless functionality to a unified system helping manage information, processes, and people.

Pharmaceutical Standards for Computerized Systems

by Siri H. Segalstad
This article compares the requirements in the 21 CFR Part 11, EU GMP Annex 11, and Part 11’s EU counterpart PI 011-2.

The FDA Answers Your Questions on Barrier Isolation Technology

The following questions and answers were provided by panelists Rick Friedman and Bob Sausville during the ISPE 15th Annual Barrier Isolation Conference, held in June 2006. These responses do not necessarily represent the positions or policies of the FDA. They are simply the panelists’ interpretations of these cGMP matters and are based on their collective experiences with isolator technology.

Departments

Global Regulatory News

New Products and Literature

Industry and People

ISPE Update

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