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Quality Management

A Process Approach to Pharmaceutical Quality Systems
€ 327.00
€ 389.13
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
pdf download
A Guide to ICH Q10 Compliance
74 Pages
ISBN: 978-3-943267-64-8
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

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 Sample

A Process Approach to Pharmaceutical Quality Systems - Reading Sample

Get started now. Order your copy of A Process Approach to Pharmaceutical Quality Systems.

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Filesize: 2,5 MB

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
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  • The invoice will be sent by postal mail as soon as possible.
Hartmann, Lothar, Ph.D.,

Chair of the Advisory Board

Peither, Thomas

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

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