What is the relationship between process design and process validation?

• A. They are the same.
• B. Process design defines intended output; process validation proves the process can reliably produce it.
• C. Validation occurs before design.
• D. Design is ceremonial.

Answer: (B)

Process design defines what the process is supposed to deliver and how it should operate to achieve that output. Process validation provides the evidence that, when the process is run within the defined parameters, it can reliably produce outputs that meet the design specifications. In practice, design sets targets, controls, materials, steps, and acceptance criteria; validation demonstrates with data that the process is reproducible, robust, and capable of delivering consistent quality. This often includes documenting equipment and facilities qualifications and collecting performance data from experiments and production runs to show process capability. The two work together as a lifecycle: design creates the plan, validation proves the plan works in real-world operation.