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Principles of Equipment Qualification

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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

e-book

99 Seiten

ISBN: 978-3-95807-083-7

1st edition 2017

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345,00 € netto

369,15 € * inkl. gesetzlicher MwSt.

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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:

Building a qualification team
Formulating a qualification plan
Documenting qualification results
Using risk analysis methods to evaluate equipment's impact on the manufacturing process

The following bonus materials are included in the report:

Instructive diagrams
Checklists for carrying out a qualification plan
FDA guidance Principles of Process Validation and
EU GMP guideline Annex 15, Qualification and Validation.

Order your copy of Principles of Equipment Qualification and understand the four phases of qualification.

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Technical Requirements

This file is in PDF format!
Filesize: 1,6 MB

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The e-book is password protected to prevent copying and modification of content.

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