Certified Pharmaceutical GMP Professional Practice

Which stage of process validation involves defining the commercial manufacturing process?

1. Process qualification

2. Process design

3. Continued process verification

4. Process review

The correct answer is: Process design

The stage of process validation that involves defining the commercial manufacturing process is process design. This phase is crucial as it sets the stage for how the drug product will be manufactured consistently and reliably on a commercial scale. During process design, key components such as raw materials, equipment, and the intended sequence of operations are established. This stage is informed by initial research and development activities, and it integrates knowledge gained from prior stages like formulation development and scale-up studies. It also takes into account how different variables can affect the quality and outcome of the manufacturing process. By clearly outlining how the manufacturing process will be carried out, organizations can ensure that they have a comprehensive understanding of the process parameters and controls that must be in place to maintain product quality and consistency. Properly developed process design is essential for successful process qualification and continued process verification in subsequent stages.