What is Qualification?

As defined in the FDA Process Validation Guidance, qualification refers to the activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly. Multiple approaches demonstrate suitability for intended use:

• Under ISPE Baseline Guide 5 approach, systems and equipment determined to have a direct impact on product quality are typically qualified using Installation Qualification (IQ) and Operational Qualifications (OQ). While systems with an indirect impact on product quality may only be commissioned.
• Commissioning activities, if performed to cGMP standards, may be leveraged during the Qualification phase as they verified the system is suitable for its intended use and demonstrated proper functionality.