FDA Validation Definitions*
Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.
Installation Qualification (IQ)
Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
Process (operational) performance qualification (OQ)
Establishing confidence that the process is effective and reproducible.
Product performance Qualification (PQ)
Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.