Selected currency: US Dollars.
Change to EUROS
 
GAMP GPG: GxP Process Control Sys, 2nd Ed - USD
GAMP GPG: GxP Process Control Sys, 2nd Ed - USD
GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (GPCS) (Second Edition) - USD
Discounted member price: 145.00
Your price: 460.00
You could save 68.5%
Quantity:

This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of Process Control Systems. It provides guidance and examples on the application of the principles and framework of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems to a wide range of systems, from basic instruments to large, complex, distributed control systems.

This Guide aims to achieve process control systems that are fit for intended use and compliant with applicable regulations; providing recommended good practice based on a life cycle approach for the development, maintenance, and management of process control systems.

The Guide applies science-based Quality Risk Management, as described in ICH Q9 and GAMP 5. It describes the system life cycle from concept to retirement, providing a high level overview of the approach together with guidance on how activities might be scaled based on risk to product quality, system novelty, and complexity as well as other project specific factors.

This publication is also available for immediate download.

Member Price: $ 145.00 / € 135.00
Non Member Price: $ 460.00 / € 400.00
Item #: GGPGPCS2US

ISBN: 978-1-936379-04-0
Pages: 196
Publishing Date: 02/11


**  New Not a Member?  Join now and get Member Pricing on your purchase!

Please note: ISPE does not pay customs or duties on international shipping.

View Our Shipping and Return Policy