Purpose of PQ
Performance Qualification (PQ) is performed to establish the stability of a process over time. In other words, the goal of PQ is to ensure that the process can consistently produce products that pass specifications under normal operating conditions.
In Japanese, it is called a performance qualification evaluation.
The term performance should not be misunderstood here. Performance does not refer to speed or processing power.
The performance of a process can be easily understood as “straight-line performance,” i.e., the ability to manufacture the 10th lot, the 100th lot, and the 1,000th lot with the same specifications and quality is a straight-line process.
Therefore, in the past, the FDA required PQs to be conducted on at least three lots.
The reason for this is that with two lots, directness can always be drawn, but with three or more lots, it is possible to tell whether the results are aligned in a straight line or not.
PIC/S GMP Anhang 15のPQ定義は下記の通りである。
Performance Qualification (PQ)
To verify and document that when facilities, systems, and equipment are assembled verify and document that they operate effectively and reproducibly in accordance with approved manufacturing methods and product standards.
PQ shall be conducted in consideration of the following
- Actual product and process parameters and methods established by OQ
- Acceptability of product standards
- Guarantee of process capability established by OQ
- Process reproducibility (repeatability), long-term process stability
In PQ, products are manufactured under the actual production conditions established in OQ. At the same time, the various action levels and the contents of the standard operating procedures (SOPs) that contain them are checked, and the process is further assured through repeated challenge tests.
Product and process data should be analyzed to determine the normal range of variation within which the output of the process is within specifications.
Knowing the normal range of variation will clarify whether it is in a controlled state or within a certain tolerance to be able to produce a specific output. This reduces and controls the range of variation and becomes a high level of quality assurance.
Depending on the characteristics and sensitivity of the process, the variables to be controlled are as follows
- Temperature/humidity/equipment exterior/condensation
- Fluctuation/vibration/light on power supply
- Environmental contamination/process water purity/human factors
- Different brands of raw materials
- Viscosity variation of raw solution due to raw material lot switching (affects product removal rate performance)
PIC/S GMP Annex 15 states that PQ can be performed simultaneously with OQ or process validation.
As a result, PQs are now rarely conducted in isolation.
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