Equipment Design and Qualification: A Guide for Drug and Device Manufacturers

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Equipment Design and Qualification
A Guide for Drug and Device Manufacturers

Before they can purchase, install and operate production equipment — sometimes whole facilities — manufacturers must evaluate their system design to make sure it can do what it’s supposed to do, a process known as design qualification.

Design qualification must account for product specifications, user’s needs, supplier’s qualifications, production timeframe, cost and, above all, the desired quality of the finished product.

This report — authored by international GMP expert Thomas Peither and associates — describes how to create and qualify a design plan that will meet the manufacturing goals and regulators’ expectations. You will learn:

  • US and EU requirements for design qualification

  • Evaluating suppliers

  • How to transfer the design plan to the supplier

  • How to determine if the supplier has met all the requirements in the design plan

  • Documenting qualification results

The report includes instructive diagrams and checklists for carrying out design qualification as well as the EU GMP guidelines’ Annex 15, Qualification and Validation.

Order your copy of Equipment Design and Qualification and understand how to design equipment systems that produce safe, effective, high-quality products that pass regulatory scrutiny.

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PDF Edition

 

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Table of Contents

  • Introduction
  • Principles of Design Qualification
  • Execution and Documentation
  • Risk Analysis in the Design Phase
  • 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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