The world’s most extensive GMP knowledge portal.
Enter the first customer review for this item
This e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ - that satisfies US and EU requirements. incl. checklists for carrying out a qualification plan and instructive diagrams
1st edition 2017
Delivery immediately after receipt of payment
Excerpt from the GMP Compliance Adviser The FDA and EMA both stress the importance of equipment qualification. If you can't prove that your equipment, operations and processes all work the way they're supposed to, you can't reliably produce a quality product and pass regulatory muster. This report lays out the basics of building a four-phase qualification plan - design qualification, installation qualification, operational qualification and performance qualification - that satisfies US and EU requirements. It covers:
The following bonus materials are included in the report:
Order your copy of Principles of Equipment Qualification and understand the four phases of qualification.
Reading Sample "Principles of Equipment Qualification"
Please enter these characters in the following text field.
This file is in PDF format!Filesize: 1,6 MB
To view PDF files, we recommend using the Adobe Reader.
The e-book is password protected to prevent copying and modification of content.
Please note the following procedure guidelines:
For payment by invoice:
When paying by credit card:
The Newsletter of GMP-Verlag
News and upcoming trends: Stay up-to-date on the latest developments in GMP!
Please select your currency