Explain the typical stages of process validation in CBM T6.

• A. Planning, Execution, Review.
• B. Design, Testing, Release.
• C. Qualification, Release, Decommission.
• D. Process Design, Process Qualification, Process Validation, Continued Verification.

Answer: (D)

The typical process validation pathway in CBM T6 follows a four-stage lifecycle that moves from designing the process to proving it can operate under control and then ensuring it remains in control over time.

First, Process Design involves outlining how the process should perform to meet quality and safety requirements, identifying the critical quality attributes and critical process parameters, and establishing the intended performance and design space. This stage sets the foundation for what the process must achieve and how it will be controlled.

Second, Process Qualification ensures the equipment, utilities, and the process can operate correctly under the planned conditions. This includes verifying that the manufacturing setup can consistently support the design, often through installation, operational, and performance qualifications to show the system is capable.

Third, Process Validation provides evidence that the process, when run under normal, intended conditions, consistently yields products that meet specifications. This typically involves producing a defined set of consecutive batches and showing reproducibility and stability within the established criteria.

Fourth, Continued Verification (also called ongoing process verification) continuously monitors the process in commercial production, collecting data, trending performance, and verifying that control is maintained over time. This stage allows updates to the control strategy if needed to keep quality consistent.

Other options miss essential elements of this lifecycle or include steps not part of the validation process, such as decommission or stages that reflect general project management rather than the validation workflow.