Process Qualification in detail

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Process Qualification is the process of demonstrating that a process is capable of consistently producing a product that meets predetermined specifications.

Process Qualification involves testing and validating a process to ensure it consistently produces a product that meets predetermined specifications.
It includes identifying critical process parameters and establishing control limits for them.
Process Qualification is typically done in three stages: design qualification, installation qualification, and operational qualification.
Examples of Process Qualification activities include process validation, equipment qualification, and software validation.

Process Qualification in detail

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