Performance qualification

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The performance qualification ( English Performance Qualification ) is a part of the plant or equipment qualification, which especially in the GMP -compliant industrial production of federally inspected products (eg. As by drugs ) as part of the quality assurance is applied. It is carried out after the installation qualification and the functional qualification to ensure the continuous quality of the measurement results, e.g. B. to ensure analytical instruments . If necessary, calibration is carried out according to standard procedures.

In pharmaceutical quality control, a basic distinction is made between three different types of laboratory equipment (according to United States Pharmacopeia : Category A, B and C). Group A (simple instruments), Group B (including thermometers , pH meters , refractometers ) and Group C (computer-controlled devices such as HPLC , GC, NIR, etc.). These are subject to various requirements in terms of their performance qualification.

With regard to analytical devices in pharmaceutical quality control, the performance qualification corresponds to the operation qualification (OQ). As a rule, the criteria for Operation Qualification are chosen less strictly than for Installation Qualification (IQ). With this procedure, the continuous operation of the devices can be guaranteed with regular calibration, without excluding devices that function perfectly under normal conditions of use.

Although there are no generally applicable requirements for device qualification, the following sets of rules are suitable starting points for creating criteria for performance qualification:

  • EC GMP guidelines, chap. 3 and Annex 15 and AMWHV, § 5
  • ISO 17025
  • For system-specific, detailed requirements: EDQM Quality management guidelines
  • General requirements of the pharmacopoeias
  • USP General Chapter <1058> “Analytical Instrument Qualification”
  • Standards (DIN, EN, ISO)

See also

Professional competence

literature

  • Thomas Peither, Dr. Petra Rempe, Winfried Büßing: GMP system qualification in the pharmaceutical industry . Maas & Peither AG - GMP-Verlag, Schopfheim, 2010, ISBN 978-3-934971-46-2

Individual evidence

  1. ↑ G. Brendelberger. USP General Chapter <1058> Analytical Instrument Qualification comes into effect on August 1, 2008 GMP-News of March 31, 2008, GMP Navigator

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