OQ & PQ protocols development for medical device two-level process validation

Abstract

Medical device industry encompasses a wide range of technologies and applications, which makes the process validation approach (IQ/OQ/PQ framework) and OQ/PQ implementation method difficult to be defined in the industry’s regulation and process validation guidance documents. Based on two-level (component production level and device assembly level) process validation approach, this article proposes 1) a typical section structure & contents for production equipment/system/process validation OQ/PQ protocols, 2) a typical subsection structure & contents for the protocols’ most critical section - Test Plan, and 3) the validation approach and OQ Detailed Test Plan for both common equipment and test equipment.

Keywords:

• Medical device process validation
• two-level process validation
• Equipment Validation IQ/OQ/PQ
• Process Validation PQ
• detailed test plan

Disclosure statement

No potential conflict of interest was reported by the author.