Cleanroom qualification in accordance with GMP

• Qualification means: demonstrating that someone or something is suitable for a certain task.
• All buildings, rooms, equipment and machines in the GMP area must be qualified in order to demonstrate that they are suitable for the specified purpose.
• The aim and scope of qualification are defined in the qualification plan and in the qualification plans for the individual stages:
       - Design qualification
       - installation qualification
       - functional (operational) qualification and
       - performance qualification (suitability and performance test)
• Every qualification plan must be approved before implementation. If changes or additions to the qualification plan are necessary during qualification, these must also be approved.
• After the tests defined in the plan are carried out, a qualification report is produced.
  In the summary qualification report, a conclusion must be given and approved by the responsible persons.
• Changes to production facilities/systems may only be carried out in accordance with the change control process. Before the change is approved, the responsible persons assess whether re-qualification is necessary.
  

  Source: PTS Training Service