Qualification and Calibration of Laboratory Instruments in Pharmaproduction (e-book)

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A number of different approaches can be taken when it comes to the qualification of analytical instruments. But which one should you take? This e-book will help you mastering all phases of qualification and calibration! incl. form for a requalification report, samples of a qualification plan and report, sample calibration SOP.

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 e-book 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?

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