Volume 26, Number 6

Table of Contents

Articles

Quality by Design, Validation, and PAT: Operational, Statistical, and Engineering Perspectives 

by Ron Branning, Lynn Torbeck, Cliff Campbell
This article demonstrates how Quality by Design (QbD) concepts can be applied to process, data, and equipment systems and addresses the implications of FDA’s Process Analytical Technology (PAT) guidance.

Regulatory Considerations and Business Implications for Automated System Suppliers

by Diarmuid P. Meagher, M. Saleem Hashmi, William G. Tuohey
This article reviews the relationships between quality and regulatory practices, and the implications for business performers for suppliers of automated systems to the pharmaceutical manufacturing industry.

Set-Up and Validation of a Clean-In-Place (CIP) System for a Coating Pan

by Stefania Ucci, Alessandro Spadoni, Caterina Funaro, Guia Bertuzzi, Roberto Trebbi, Giovanni Ciaramella, Paolo Colombo, Ruggero Bettini
This article presents a study of cleaning performed to a clean coating pan in compliance with Health Canada’s updated guidelines on cleaning validation.

Industry Interview Series: Gordon Munro, PhD, Senior Vice President, Quality Assurance, Watson Pharmaceuticals 

Dr. Munro discusses the state of quality and compliance today, relating his experiences gained from high-level roles in industry and regulation. He shares his thoughts on major industry challenges ahead, including generics, biotechnology, the relationship between the regulator and the regulated, and harmonization.

Practical Risk Management

by David Stokes
This article presents an overview of the comparative risks between the pharmaceutical industry and other industries, placing the hazards of pharmaceutical products in a context of overall public safety.

Process Review for PAT – Selecting Cost Efficient PAT Projects

by Alex Brindle, Per Vase
This article presents a logical way to begin implementing PAT projects within an organization with an objective focus on return on investment based on process expertise, facts, and data.

Current Good Validation Practice

by Brian Collins, Kieran Sides
This case study presents how a site validation policy was developed using a modular validation approach and incorporating the latest FDA initiatives, as well as principles from ISPE’s Commissioning and Qualification Baseline® Guide, GAMP® 4, and the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems.

Implementing Industry Focus Groups to Identify Skills and Knowledge Expectations for Recent College Graduates

by Jon Tomson, John E. Connors, Matthew A. Wells
This article describes a process that was developed and successfully used to directly solicit and capture the opinions and insight of individuals in the pharmaceutical industry in a format that could assist a university with development of a new graduate program.

Departments

Industry and People

New Products and Literature

ISPE Update

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