Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

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Principles of Equipment Qualification
A Guide for Drug and Device Manufacturers

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 — authored by international GMP expert Thomas Peither and associates — 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 guidelines’ Annex 15, Qualification and Validation.

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

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Table of Contents

  • Introduction
  • Official Requirements and Agency Expectations
  • Design Qualification
  • Installation Qualification
  • And More …

View the entire TOC

About the Authors

Thomas Peither and associates
Thomas Peither has been a GMP consultant for 18 years and an expert in the European GMPs. He cofounded the GMP publishing company Maas & Peither (Germany, USA) and the midsize pharma consulting company Halfmann Goetsch Peither (Switzerland, Germany, Singapore), which advises numerous pharmaceutical companies.

Who Will Benefit

  • Quality assurance/control
  • Engineering staff
  • Equipment managers
  • Production head
  • Systems designers

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