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 ebook 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. Order your copy of A Process Approach to Pharmaceutical Quality Systems.
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