What Is Operation Qualification and Performance qualification?

Let’s understand what is operation Qualification Performance qualification, for an equipment, instrument or and clean room area itself, approval of an URS, Design qualification, installation Qualification, Operational Qualification and Performance qualification are steps in the equipment validation process. These all together form the validation process of an equipment in the pharma industry. Of these we will discuss Operational qualification and Performance qualification here in this article.

Evaluating an equipment for its operation capabilities and confirming that the equipment is capable of the intended operations as per the URS, is called as operation qualification.

Example of operational qualification:

Tablets compression machine: In simple words, the tablets compression machine along with existing dies and punch set, is capable of yielding tablets with desired weight, at desired speed, with the permissible weight variation, permissible variations in thickness, hardness. During the operation all the variables on the machine weight setting gaze and the weight of the tablet increase and decrease are exhibited as desired. These parameters data are collected in tabular form and evaluated.

Performance qualification is the process of evaluating the equipment or the area which is already design qualified and correctly installed, its operation is qualified for intended use. The performance qualification considers longer operation capabilities, on the actual production run.

Example of Performance Qualification Tablet compression machine:

To qualify a tablet compression machine after the stages as described above, a written protocol is prepared and approved by QA.

The protocol evaluates a minimum of three consecutive actual production batches on the compression machine. Therefore, it will have procedures to verify the initial line clearance, to weight setting parameters, weight variation profile of compressed tablets sampled intermittently during the progress of the compression of the batch. Hardness, Dissolution test, Disintegration test. Thickness, weight variation test.

The results obtained for the various tests must be within the limits for each test, and should be comparable with the tablets compressed on other qualified machines.

Why three consecutive batches are taken for equipment qualification:

During the first batch settings are confirmed,

During the second batch the corrections are implemented.

During the third batch reproducibility of the results is verified.

Therefore, always three consecutive batches must be considered for Equipment validation.

What to do if any out of specification results are obtained during performance qualification?

It’s likely that during performance qualification due to some factors products results like weight variation, or DT, etc. may go out of specification. Deviation and OOS Should be logged and root cause must be identified, and corrective and preventive action should be implemented after approval of deviation to proceed for the batch.

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