FDA 2011 Process Validation Guidance: Process Validation Revisited

Background In January 2011, FDA announced the availability of a final guidance for industry entitled Process Validation: General Principles and Practices (the 2011 Guidance). The 2011 Guidance revises and replaces FDA’s Guidance for industry entitled Guideline on General Principles of Process Validation, issued in May 1987 (the 1987 Guideline). The 2011 Guidance defines process validation as “the collection and evaluation of data, from the process design stage through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality product.” The 2011 Guidance promotes a “lifecycle” approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. In particular, the 2011 Guidance describes process validation activities in three stages: • In Stage 1, process design, the commercial process is defined based on knowledge gained through development and scale-up activities. • In Stage 2, process qualification, the process design is evaluated and assessed to determine if the process is capable of reproducible commercial manufacturing. • In Stage 3, continued process verification, ongoing assurance is gained during routine production that the process remains in a state of control.