Enter the first customer review for this item
This pdf download 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
e-book / PDF-Download
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.
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.
If you choose payment by bank transfer:
If you choose payment by credit card:
A qualification serves to prove that equipment is fit for its given purpose. So far, so good....
A number of different approaches can be taken when it comes to the qualification of analytical...
With this GMP newsletter you will be regularly informed on the latest developments in GMP.