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Innovations

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

Pages 431-442 | Received 01 Aug 2019, Accepted 08 Nov 2019, Published online: 28 Nov 2019
 

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.

Disclosure statement

No potential conflict of interest was reported by the author.

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