Der Artikel wurde erfolgreich hinzugefügt.

Qualification and Validation: Agency Expectations

Enter the first customer review for this item

A qualification serves to prove that equipment is fit for its given purpose. So far, so good. But what are the actual fundamental requirements for a successful equipment qualification, and what are the core elements of qualification work?


57 pages

ISBN: 978-3-95807-098-1

1st edition 2018

Delivery immediately after receipt of payment

€117.00 net

€125.19 * prices incl. VAT


Excerpt from the GMP Compliance Adviser

The ultimate prerequisites for GMP-conform pharmaceutical manufacturing are validated processes and qualified equipment! Qualification and validation should prove that the equipment, the procedures and processes used during the manufacture of medicinal products are suitable for their purpose. Previously defined acceptance criteria for the critical quality attributes and process parameters have to be met reproducibly.

This sounds plausible. However, the practical implementation raises many questions. How do you correctly use risk management? By what means can the life cycle concept be realised? How do you organise planning, performance and documentation efficiently and in a GMP-conform manner? And most important of all, what are the expectations of the responsible authorities?

In this report Michael Hiob provides all the answers. It is a “must have” guidance for all those who are involved in qualification and validation

You'll learn in detail about:

  • The Regulatory requirements for qualification and validation
  • Risk management and life cycle concepts
  • Organisation and responsibilities
  • Performance and documentation

Available downloads:

Reading Sample "Qualification and Validation: Agency Expectations"

Customer reviews can be made anonymously and will be published in our webshop after verification.
Write a customer review

Please enter these characters in the following text field.

The fields marked with * are required.

  • Persons who are responsible for the qualification and validation in the areas of quality management, quality assurance, quality control and production
  • External service providers who support qualification and validation
  • Suppliers of facilities and equipment
  • Persons who are responsible for qualification and validation documents

Technical Requirements

This file is in PDF format!
Filesize: 2,22 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.
  • Inspection of Process Validation - Cover
    Do your validation processes meet their specified requirements? This bilingual guide offers an...

    €59.00 net

    63.13 - 7.00

  • Principles of Equipment Qualification - Cover
    This e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ...

    €345.00 net

    369.15 - 7.00

  • Managing Process Validation - A Drugmaker's Guide
    A step-by-step guide based on real-world examination experience. Discover how to document...

    €345.00 net

    369.15 - 7.00


    The Newsletter of GMP-Verlag

    News and upcoming trends: Stay up-to-date on the latest developments in GMP!

    > Subscribe now free of charge!