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 e-book helps you bring your drug manufacturing quality systems into compliance.
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 implement 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.
Reading SampleA Process Approach to Pharmaceutical Quality Systems - Reading Sample
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Chair of the Advisory Board
Since 1994 Thomas Peither is working as expert, publisher and consultant in the area of Good Manufacturing Practices for the pharmaceutical industry. In 1999 he co-founded Maas & Peither specialised in publishing professional GMP information and is editor-in-chief. As Peither & Consultants he delivers GMP services for the commercial drug manufacturing