A Process Approach to Pharmaceutical Quality Systems A Guide to ICH Q10 Compliance
The FDA adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board.
A pity, then, that most drugmakers didn’t use a lifecycle approach when ICH Q10 made its bow ... and didn’t have a clue as to how to begin.
Many still don’t.
But worry not — help is at hand.
This management report from FDAnews helps you bring your drug manufacturing quality systems into compliance.
A Process Approach to Pharmaceutical Quality Systems: A Guide to ICH Q10 Compliance is written by Lothar Hartmann, PhD, and Thomas L. Peither, two pharmaceutical industry veterans with more than 25 years of combined experience.
In only an hour or so of study, you’ll discover how to look beyond the multiple silos that so easily develop around individual drugmaking activities. You’ll be ready to begin instilling new problem-solving approaches at every level of your manufacturing operations.
A Process Approach to Pharmaceutical Quality Systems walks you step by step through the processes and procedures you’ll need to put in place. Here’s what you’ll learn:
How to restructure your quality systems to satisfy GMP, and specifically ICH Q10
Sample key performance indicators and assessment schedules
Strategies to ensure management buy-in at every level
Developing effective process maps — a step-by-step approach
Establishing meaningful quality objectives
Integrating the quality system throughout the entire product lifecycle
The lifecycle process approach is an orderly and effective way of taming the quality system. Once you’ve mastered it, you’ll wonder why you waited. Get started now.
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Lothar Hartmann, PhD, was involved in the ICH development processes as a representative of industry. He is now head of quality for Crucell Switzerland AG, a J&J company.
Thomas L. Peither has been a GMP consultant for 18 years and is an expert in the European GMPs. He co-founded the GMP publishing company Maas & Peither (Germany, USA) and the midsize pharma consulting company Halfmann Goetsch Peither (Switzerland, Germany, Singapore), which advises numerous pharmaceutical companies.
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Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.
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