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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
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:
The following bonus materials are included in the report:
Order your copy of Principles of Equipment Qualification and understand the four phases of qualification.
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