Approval Workflow

An Approval Workflow is the structured, documented sequence of reviews and authorizations to ensure that regulated products and their design changes meet regulatory and quality requirements before market release. In practice, it ensures that data, labeling, manufacturing readiness, and risk assessments are reviewed by qualified functions (Quality, Regulatory, Clinical, Manufacturing) before regulatory submission or market release. 
 
For example, a formulation change cannot proceed without documented cross-functional approval. The approval shall confirm regulatory impact, patient safety, and compliance. Effective approval workflows improve traceability, prevent unauthorized changes, and support inspection readiness.