Validation Protocol

Validation Protocol. This Validation Protocol establishes the documented evidence that provides a high degree of assurance that the specific process, method, equipment, or system consistently produces a result meeting its predetermined specifications and quality attributes, in accordance with 21 CFR Parts 210, 211, and 820, and applicable FDA Guidance for Industry. The validation shall follow the lifecycle approach consisting of: Stage 1 — Process Design, which includes defining the process and identifying critical process parameters (CPPs) and critical quality attributes (CQAs); Stage 2 — Process Qualification, which includes facility, utility, and equipment qualification (IQ/OQ/PQ), and Performance Qualification (PPQ) demonstrating that the process is capable of reproducible commercial manufacture; and Stage 3 — Continued Process Verification, which provides ongoing assurance that the process remains in a state of control during routine production. Acceptance criteria for each validation stage shall be predefined and documented. Any deviations from the validation protocol shall be documented, investigated, and assessed for their impact on validation conclusions. The validation shall not be considered complete until all acceptance criteria have been met and a final validation report has been approved by the Quality Unit.