Volume 27, Number 6

Table of Contents

Articles

PAT and QbD – Effects on 21st Century Laboratories in Development and Manufacturing

by Alex Brindle, Line Lundsberg-Nielsen
This article discusses the influence of PAT and QbD on Quality Control Laboratories and provides examples relating to changes occurring within laboratories connected to manufacturing and development.

Energy Savings in Pharmaceutical Facilities: A Risk-Based Approach

by Dave Goswami, Mark Butler
This article provides an in-depth look at the general risk profiles in the pharmaceutical industry and evaluates the place of energy saving features within the context of risk management.

Industry Interview Series: Dr. Carl Lawton

Dr. Carl Lawton discusses how academia, industry, and government are working together to help biopharmaceutical companies in Massachusetts transition from drug discovery to manufacturing quickly and efficiently. He also discusses related training programs that are educating future and current biomanufacturing employees in process development and process validation.

Commissioning and Qualification: A New ASTM Standard – GMP Regulations

by Robert E. Chew, David Petko
This article clarifies the principles and practices in the new ASTM Standard and presents how the new standard will impact the ISPE C&Q Baseline® Guide Revision.

US FDA Office of Generic Drugs’ Pharmaceutical Quality Initiative: Progress and Feedback on Question-based Review

by LaiMing Lee, Robert Lionberger, Lawrence Yu, Christine Mundkur, Gordon Munro, Gordon Johnston, Joseph Famulare
This article presents the US FDA-Office of Generic Drugs’ Pharmaceutical Quality Assessment Initiative that was presented at the February/March 2007 Pharmaceutical Quality Workshop in Bethesda, Maryland. At the meeting, ISPE representatives invited the FDA to submit an article on OGD’s new CMC review paradigm for publication.

Programming of Quality Laboratories Using Work Flow Analysis

by William E. Ferguson
This article presents the application of workflow analysis to create a laboratory design program. Two case studies involving quality laboratories demonstrate the applicability of this technique. The benefits to both management and staff are discussed.

Drug Pedigrees: Your Supply Chain Needs Them. Are You Ready?

by Norm Howe, Stephen Goldner, Chris Fennig
This article describes the challenges represented by counterfeit drugs and the consequences for companies that fail to recognize the threat to their value chain. It outlines the technical solutions that are available, assesses the merits of those solutions, and shows which solution fits best in different situations. 

Departments

ISPE Update

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Global Regulatory News

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