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Principles of Equipment Qualification
€ 345.00
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Excerpt from the GMP Compliance Adviser

A Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.
Edition: 1st edition 2017
98 Pages
ISBN: 978-3-95807-083-7
Delivery: immediately after receipt of payment
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.

Reading Sample

Principles of Equipment Qualification - Reading Sample

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  • qualification
  • quality assurance
  • facilities
  • manufacturing
  • engineering
Hiob, Dr. Michael

After graduating in Pharmacology and receiving a PhD, he worked as Laboratory Manager and GMP Inspector. He is currently responsible for supervising GMP inspections. As a ministerial advisor, he is currently responsible for supervising GMP inspections.



Peither, Thomas

Since 1994 Thomas Peither is working as expert, publisher and consultant in the area of Good Manufacturing Practices for the pharmaceutical industry. In 1999 he co-founded Maas & Peither specialised in publishing professional GMP information and is editor-in-chief. As Peither & Consultants he delivers GMP services for the commercial drug manufacturing



Reuter, Ulrike

Ms Reuter has been working for Sanofi-Aventis since 1989 in different technical positions. As an engineer in a pharmaceutical company, she strives to reconcile technical and GMP requirements. She is currently working on implementing the new Annex 15, Annex 11 and other technical GMP issues as part of operational support and project management.

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A Process Approach to Pharmaceutical Quality Systems
Quality Agreement
Qualification and Validation: Agency Expectations