FDA Guidelines for implementing Continuous Improvement Process


Involved In Discussions
Does anyone know where I can find FDA Guidelines for implementing Continuous Improvement Process for Medical Device industry? Your input would be greatly appreciated Thank you!!


Quite Involved in Discussions
I think you mean Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control in the Guidance for Industry Process Validation: General Principles and Practices of 2011.
It is not specific to the medical device industrie.

Ronen E

Problem Solver
Maybe there's a misunderstanding here.
Continuous Improvement Process is not the same as Continuous Process Improvement.

I'm not aware of a specific FDA guidance for medical device manufacturers on Continuous Improvement Process. In my understanding continuous improvement can be achieved through a systematic and consistent application of a quality management system such as that prescribed by 21 CFR 820.

This document discusses Innovation and Continuous Improvement in Pharmaceutical Manufacturing.

Chapters IV & V of this document seem to be relevant too, though targeted at pharmaceuticals manufacturing.
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