Process validation involves a series of activities taking place over the lifecycle of the product and process. There are three stages for process validation activities.

Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on KNOWLEDGE gained through development and scale-up activities.

Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3 – CONTINUED Process Verification: Ongoing ASSURANCE is gained during routine production that the process remains in a state of control.

Process validation involves a series of activities taking place over the lifecycle of the product and process. There are three stages for process validation activities.

Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.