Process Validation

 Process validation is the process of establishing documented evidence that a manufacturing process consistently produces a product that meets predetermined specifications and quality attributes. Process validation is an essential component of quality assurance and is required by regulatory agencies in industries such as pharmaceuticals, medical devices, and biotechnology.

The process validation typically involves three stages:

1.    Process Design: The first stage of process validation is process design. During this stage, the process is designed to meet the predetermined specifications and quality attributes. This includes identifying critical process parameters and establishing the ranges within which these parameters must be maintained to ensure product quality.

2.    Process Qualification: The second stage of process validation is process qualification. During this stage, the process is evaluated to ensure that it is capable of consistently producing a product that meets the predetermined specifications and quality attributes. This includes executing a series of process performance qualification (PPQ) runs to demonstrate that the process is in control and capable of producing the desired product quality.

3.    Continued Process Verification: The final stage of process validation is continued process verification. During this stage, the process is monitored and evaluated on an ongoing basis to ensure that it remains in control and continues to produce a product that meets the predetermined specifications and quality attributes. This includes ongoing monitoring of critical process parameters, as well as ongoing process validation activities such as annual product reviews.

The process validation process is iterative and requires ongoing monitoring and evaluation to ensure that the process remains in control and continues to produce a product that meets the predetermined specifications and quality attributes. The process validation activities are documented in a validation master plan and the results are summarized in a validation report, which is subject to review by regulatory agencies.

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