- Installation Qualification (IQ)
Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer's approved specification and that the recommendations of the supplier of the equipment are suitably considered.
- Operational qualification (OQ)
Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.
- Performance Qualification (PQ)
Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.
Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.
- Process Validation Protocol
A document stating how validation will be conducted, including test parameters, product characteristics, manufacturing equipment, and decision points on what constitutes acceptable test results.
Confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled.