November/December 2007
Volume 27, Number 6
Theme: Laboratory Facilities
Table of Contents
Articles
Energy Savings in Pharmaceutical Facilities: A Risk-Based Approach
by Dave Goswami, PE and 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.
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Industry Interview Series: Dr. Carl Lawton, Director of Massachusetts BioManufacturing Center (MBMC) and Associate Professor, Department of Chemical Engineering, UMass Lowell
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.
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Commissioning and Qualification: A New ASTM Standard – GMP Regulations
by Robert E. Chew and 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.
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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, and 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.
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Programming of Quality Laboratories Using Work Flow Analysis
by Dr. 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.
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Drug Pedigrees: Your Supply Chain Needs Them. Are You Ready?
by Norm Howe, Stephen Goldner, and 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.
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