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Process Validation parameters


Parameters of Process Validation for successful validation of any process are discussed here. Some of the key parameters in process validation are as follows, so let us check it out one by one.

The knowledge and the information about the product and the process is very necessary.

Understanding of the source of variation is required for successful process validation.

One must be aware about the impact of the variation on the process and ultimately on the products which is being manufactured.

Risk analysis must be done and the corrective and preventive actions are planned.

The manufacturer must have the sufficient knowledge about the process.

The material, equipment or the process parameters must be be verified and checked if they are qualified for intended use or not.

Personnel should be trained before carrying out or operating any equipment.

The data of the product and the process are collected regularly and evaluated in order to control variation and to maintain quality of products.