This post was written by Paul Sheives.

FDA has issued a final guidance document entitled “Process Validation: General Principles and Practices,” which replaces FDA’s 1987 “Guideline on General Principles of Process Validation.” The guidance is intended to outline the general principles and appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances). The guidance seeks to meld process validation with the product life cycle concept, which links product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. The document addresses the three stages of process validation (process design, process qualification, and continued process verification), concurrent release of process performance qualification batches, documentation, and analytical methodology.