• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Shopping cart
Your shopping cart is empty

Show shopping cart...

Image

Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices

 

>>> REGISTER for our free GMP Newsletter LOGFILE

GMP Subject Downloads

A Process Approach to Pharmaceutical Quality Systems
€ 265.00
net
€ 315.35
  19% VAT included
PDF-Download
US$
377.00
A Guide to ICH Q10 Compliance
74 Pages
ISBN: 978-3-943267-64-8
Excerpt from the GMP MANUAL

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 ebook 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 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.

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.

Technical Requirements

This file is in PDF format! To view these files, you need Adobe Reader installed on your computer. If you don't, you will need to download and install it.

>>> Adobe Reader - free download

A Process Approach to Pharmaceutical Quality Systems: A Guide to ICH Q10 Compliance
is written by Lothar Hartmann, PH.D., and Thomas Peither,
two pharmaceutical industry veterans with more than 25 years of combined experience.
Recommendations
GMP Compliant Documentation
GMP Audit Checklist (Download)