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Qualification and Calibration of Laboratory Instruments in Pharmaproduction
€ 117.00
€ 139.23
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pdf download
Excerpt from the GMP Compliance Adviser

Edition: First edition 2018
46 Pages
ISBN: 978-3-95807-101-8
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

Qualification of equipment is a basic GMP requirement. This also applies to laboratory equipment. Remember: Qualification begins as soon as a decision has been made to purchase an instrument – and not when a particular instrument has been chosen, procured or even installed!

In contrast to the validation of analytical methods there are no specific directives or methods that apply to the qualification of analytical instruments. This means that a number of different approaches can be taken. But which one should you take?

The pdf download Qualification and Calibration of Laboratory Instruments in Pharmaproduction leads you safely through all steps of qualification and calibration.

The report answers the following questions:
  • What instruments have to be qualified?
  • How is the qualification carried out?
  • What qualification documentation has to be created?
  • What scope of qualification is both useful and necessary?
  • How is instrument software validated?
  • What has to be done when the configuration of an instrument is changed?
  • How are instruments managed?
  • Which instruments have to be calibrated?
  • How and how often is calibration carried out?
  • What needs to be done if calibration is not successful?
  • How is calibration documented?
  • What level of maintenance is required for laboratory instruments?
A form for a requalification report, samples qualification plan and qualification report and a sample calibration SOP are included as bonus materials.

Order your copy of Qualification and Calibration of Laboratory Instruments in Pharmaproduction and master all phases of qualification and calibration!

Technical Requirements

This file is in PDF format!
Filesize: 1,16 MB

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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.
  • Engineering
  • Persons who are responsible for qualification documents
  • Laboratory
  • Quality control
Künzle, Dr. Josef

Josef Künzle joined Basilea in 2007. In August 2015, he was appointed Head of Global Quality Management and is responsible for all GxP departments. He had previously worked in the pharmaceutical industry for 18 years in the areas of analytical R&D, quality control and quality management. He has taken part in official inspections and global supplier audits.

GMP Compliance Adviser
Single User Licence (monthly subscription)
Qualification and Validation: Agency Expectations
Principles of Equipment Qualification