The process of Chamber qualification is identified in CFR 21 part 211, subpart C. In Guidance for Industry Process Validation: General Principles and Practices on page 10 section C paragraph 2 states
“Here, the term qualification refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly. These activities necessarily precede manufacturing products at the commercial scale”
This reference includes Stability chambers as they support the verification process of the manufacturing process.
In the qualification process of a chamber the testing of the chamber is broken down into three qualification processes; the Installation Qualification, (IQ), Operating Qualification, (OQ), and Performance Qualification (PQ). Together these qualifications support and document the proper operation of the chamber.
The Installation Qualification (IQ) should be performed to document that the requirements of the DQ were met and the chamber is installed correctly. In the IQ, the requirements of the Design Qualification DQ are tested at a more detailed level to document the equipment as it is installed correctly.
The Operating Qualification (OQ) is a documentation of the chamber meeting the intended design specifications. During this testing the intended processes are challenged to meet the requirements of the Design Qualification (DQ). This testing is not a duration test it is only a performance test.
The Performance Qualification is duration testing of the operation of the chamber. In this testing, the operational requirements identified in the DQ are tested for a specified duration of time to show the ability of the unit to perform at a specific setting for a timed period of time.
In the generation of each protocol, the detail of each step in the process needs to include a description of the step, an expected result and a documentation of the result.
The OQ and PQ testing can be combined into a single process with a discussion of the combination in the protocol.
When performing the Operating Qualification (OQ)/Performance Qualification (PQ) the documentation is merged and documented during the process.
In the requalification of a chamber the protocol used for the OQ/PQ should be used in a modified format. The modification should include the verification of processes at the same conditions and times as the original validation. The chamber requalification should be completed at the current level of capacity. A door test is not required, but can be included to document the response at the current capacity.
During the OQ/PQ a remapping of the unit, it should document and support the placement of the monitoring thermometer or EMS probes(s). A discussion of the results discussing the data and any changes it may show. If a hot or cold spot location changes, a discussion of the change and the impact to the operation of the chamber needs to include in the Final Report
A Final Report that details and over view of each test should be written. In the discussion of the qualification run(s), tables and graphs should be used to show the response to tests that have large data files, such as temperature runs. The report should support and state that the data in the validation verifies that the chamber is qualified to run at the tested temperature.