We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Books » Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

Other Options

PDF Edition

$397.00

PDF Edition - 3-4 Copies (10% Off)

$357.00

PDF Edition - 5-6 Copies (15% Off)

$337.00

PDF Edition - 7-9 Copies (20% Off)

$317.00

PDF Edition - 10+ Copies (25% Off)

$297.00

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

$397.00
Books

Product Details

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.

Order Your Copy Today

PDF Edition

 

Available Format

PDF Edition — $397

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

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing