Principles of Equipment Qualification
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
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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.
Reading Sample "Principles of Equipment Qualification"
- quality assurance
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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