Protocol

Installation Qualification Protocol | IVT

Based on the outcome from the DQ and initial equipment evaluation, such as testing of the equipment at the vendor site (e.g., FAT), and/or SAT conducted upon initial receipt of the equipment, a formal Installation Qualification (IQ) protocol can be developed. When the equipment and the vendor certifications are received, IQ can proceed. Based on the Design Qualification (DQ) report or executed Factory Acceptance Test (FAT), or red-lined FAT protocol, with required changes, design of the IQ protocol can proceed.

The IQ protocol should provide complete instruc- tions for performing the IQ requirements for equipment. In addition, SOPs for operation, calibration, cleaning, maintenance of the equipment, as well as associated logbooks, should be established. The equipment manu- facturer’s operation and installation manual is typically a good source of information for drafting these SOPs.

It is recommended that a pro- spective equipment protocol be written and approved for the equipment IQ, OQ, and PQ. In some cases, combining the IQ and OQ to form an Installation-Operational Qualification (IOQ) protocol is ac- ceptable, provided the completion of the IQ is verified and documented prior to execution of the OQ. The qualification protocols are control documents, just like SOPs and batch records, and require final approval be- fore and after execution by the quality unit.

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