Clean air conditioning system performance confirmation PQ

The performance confirmation of the clean air conditioning system PQ IQ installation and OQ operation confirmation is completed and meets the requirements before the performance can be confirmed
.
In some cases, performance validation can be combined
with operational validation or process validation.
PQ performance confirmation is the provision of evidence that systems and equipment can operate
repeatedly and efficiently according to approved process methods and product quality standards.
This phase describes a series of activities
required to demonstrate that the verification target is capable of consistently producing a qualified product using established equipment/facilities, procedures, methods and standards under normal operating conditions.
Demonstrate consistency
by running multiple times.
The number of batches for PQ is determined by the risk assessment, and in most cases, 3 batches of product production
must be successfully and continuously performed in PQ.
PQ will have a higher level of sampling and additional inspection, as well as a more careful scrutiny
of process performance compared to typical conventional commercial production.
The level of monitoring and testing should be sufficient to confirm the uniformity of product quality within a batch and the stability
of product quality between batches under the same process conditions.
The performance of the clean air conditioning system can be confirmed after PQ 1, installation and operation confirmation is completed and meets the requirements
.
In some cases, performance validation can be combined
with operational validation or process validation.
2.
Performance confirmation plans should be formulated according to the relevant knowledge of existing production processes, facilities and equipment, and test / test using production materials, appropriate substitutes or simulated products; The frequency of sampling required during testing should be evaluated
.
3.
When there is a computerized system (such as a class 3 computerized system) that is confirmed together with the equipment, the stability and reliability of the computerized system in actual operation/process should be evaluated
at this stage.
The PQ must operate under normal operating conditions, including the following sections: Verify the parameters within the scope Perform in the intended operating environment Use the person expected to perform these tasks Operating procedures are in effect Clean air conditioning system performance confirmation PQ PQ scheme must contain acceptance criteria
related to quality attributes that meet the requirements of the product specifications.
The acceptance criteria must be based on the principles
of scientific rationality or statistical reasonableness.
You must use statistical methods to select an appropriate sampling plan
.
PQ must have a higher level of sampling, additional testing and/or more rigorous process performance review
than conventional commercial production.
PQ operation test content depending on the specific implementation, equipment, system may usually include: monitoring of equipment parameters using attribute sampling or variable sampling (high confidence) to test quality attributes yield monitoring process capability index Cpk evaluation or other process monitoring PQ production of products must meet all the conditions for product release before release
.
Clean air conditioning system performance confirmation PQ execution of new plant equipment confirmation PQ uncertainty factors are too many, it is recommended to perform alone or with trial production, not recommended to be performed
together with process verification.
The selection of the simulator is as close as possible to the actual production state, so that the PQ result is more informative
.
If the guidelines do not guide the number of performance confirmations, the number of times the enterprise needs to make choices based on the risk level of the project and whether there is reproducibility significance, such as 3 consecutive times
.
After the PQ is completed, according to the complexity of the equipment, the complex equipment or project should consider the confirmation of the general report of the additional equipment, and the deviations, changes related to the equipment and the corresponding results of all URS are summarized and evaluated
.