Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

Process verification and process validation are two important—and commonly misunderstood—activities in the development of medical devices. This document explains the …

The Global Harmonization Task Force (GHTF) [3] defines process validation as ‘a term used in the medical device industry to indicate that a process has been subject to such scrutiny that …

Oct 17, 2024 · Process validation serves as a proactive measure, identifying potential issues from failure in production before the medical device reaches the market. As such, process …

May 28, 2024 · In the medical device industry, even one failure in a manufacturing process can lead to devastating consequences for patients, so let’s dig into IQ, OQ, and PQ and the role …

The goal of process validation is to produce a stable medical device manufacturing process that offers consistent performance. Variation is minimal and predictable.

In this article, we provide a concise yet relevant guide to process validation in medical device manufacturing. We will walk you through the fundamentals – from the definition of process …

Aug 13, 2024 · To achieve effective production verification, manufacturers should adhere to several best practices: Clear specifications: Ensure that production specifications are well …

Meet FDA requirements and learn the principles and application of successful process validation. Whether you’re new to process validation, or seeking to refine your process, this practical …

Aug 27, 2023 · Process validation is the objective demonstration, through the collection and careful evaluation of data, from design to commercial use, that a process is highly likely to …