Der Artikel wurde erfolgreich hinzugefügt.

Qualification and Validation: Agency Expectations

Geben Sie die erste Bewertung für diesen Artikel ab

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 Seiten

ISBN: 978-3-95807-098-1

1st edition 2018

Lieferung sofort nach Zahlungseingang

117,00 € netto


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

Bewertungen werden nach Überprüfung freigeschaltet.
Bewertung schreiben

Bitte geben Sie die Zeichenfolge in das nachfolgende Textfeld ein.

Die mit einem * markierten Felder sind Pflichtfelder.

  • 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.

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
    • EU-GMP-Leitfaden Anhang 15
    • WHO: Validierung nicht steriler Prozesse

    25,00 € netto

  • Qualification and Calibration of Laboratory Instruments in Pharmaproduction

    A number of different approaches can be taken when it comes to the qualification of analytical...

    117,00 € netto

  • Inspection of Process Validation

    Do your validation processes meet their specified requirements? This bilingual guide offers an...

    59,00 € netto

  • Principles of Equipment Qualification

    This e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and...

    345,00 € netto

  • SOP 501 Qualifizierung von Anlagen und Geräten

    Gibt es bei Ihnen eine einheitliche Vorgehensweise bei der Qualifizierung von...

    189,00 € netto



    Lesen Sie GMP-News und informative Beiträge zum Thema GMP in unseren kostenlosen GMP Newsletter "LOGFILE".