Hi, we purchase new drying oven.I have to perform its PQ.I don’t understand what is PQ for oven:If somone knows it please write me.
Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Sometimes the performance qualification is performed by power users as the system is being released.
Depending on your needs and the complexity of the system, the Performance Qualifications can be combined with Installation Qualifications or Operational Qualification.
Performance Qualifications should be approved before protocol execution. A copy of the unexecuted protocol should be kept in the validation package. The unexecuted protocol should be approved by the System Owner and Quality Assurance. The executed protocol should be signed by the tester and reviewed by the system owner and Quality.
Each step of the qualification should include an instruction, an expected result and the actual result. Any discrepancy between the expected result and the actual result should be tracked as a deviation. Deviations should be resolved before validation is complete.
For drying oven PQ is temperature mapping of the chamber when the chamber is fully loaded. If it is vacuum drying oven then temp.mapping and pressure monitoring. Acceptance criteria is that temperature is in the range you need for load inside (example: drying of material at 105±2oC for 12h)
Dear Zeljko Joksimovic
Thanks for information
Best Regards K. Arzakanyan