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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


99 Seiten

ISBN: 978-3-95807-083-7

1st edition 2017

Lieferung sofort nach Zahlungseingang

345,00 € netto


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.

Weitere Informationen

Reading Sample "Principles of Equipment Qualification"

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  • qualification
  • quality assurance
  • facilities
  • manufacturing
  • engineering

Technical Requirements

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:

  • You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
  • After receipt of payment you will receive an e-mail with the download information.

When paying by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • Your invoice will be sent in a separate e-mail within 1-2 working days.

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  • Qualification and Validation: Agency Expectations - Cover
    A qualification serves to prove that equipment is fit for its given purpose. So far, so good....

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