New: English translation Aide memoire Qualification and Validation for Inspectors

GMP legislation and guidelines are occasionally not very specific. The pharmaceutical industry is seeking more concrete interpretations, though, especially coming from regulators. An example for a guide substantiating requirements is the guide "Aide memoire Qualification and Validation - Basic Requirements" for inspectors. 

This guide was developed by the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) and shows the current state of the art. The 20 pages document covers

  • Responsibilities regarding qualification and validation 
  • Risk assessments 
  • Documentation (Validation Master Plan, Qualification Master Plan, Validation/Qualification protocols and reports) 
  • Inspection of premises and equipment 
  • Qualification requirements (URS, DQ, IQ, OQ, PQ) 
  • Qualification of identical equipment, 
  • Requalification

The document was published in German language only. However, as a participant of ECA´s Validation Manager Course in Barcelona, Spain, from 19-21 Febnruary 2020 you will get a translated version free of charge.

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