Addressing the Critical Gaps in Process Validation within Medical Device Manufacturing

Authors

Premsanth Sadasivam

Abstract

Process validation is a fundamental aspect of manufacturing medical devices, ensuring that the products consistently meet essential safety, regulatory, and performance standards. Despite its importance, many manufacturers face substantial obstacles in implementing effective process validation, leading to compliance problems, defects in products, and risks to patient safety. This paper aims to identify the main causes of these gaps, such as human errors, outdated technologies, and inadequate training. It explores the serious consequences of these shortcomings, including regulatory penalties, product recalls, and harm to patients, while offering practical solutions. By adopting modern technologies, improving documentation procedures, and fostering a culture of continuous improvement, manufacturers can ensure better regulatory adherence, product quality, and patient safety. This paper also integrates emerging trends and technological innovations that contribute to process validation.

Keywords

Process Validation, Medical Device Manufacturing, Regulatory Compliance, Product Quality, Process Monitoring, Advanced Analytics, Digital Transformation.

Addressing the Critical Gaps in Process Validation within Medical Device Manufacturing. Premsanth Sadasivam. 2020. IJIRCT, Volume 6, Issue 3. Pages 1-5. https://www.ijirct.org/viewPaper.php?paperId=2502009