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New FDA Guideline on Process Validation - General Principles and Practices

J

jameswalsh

#11
#11
Does anyone know if the FDA?s January 2011 Guidance document ?Process Validation: General Principles and Practices? the most up to date FDA guidance document on process validation?

Thanks,

James Walsh
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#13
#13
Please note that

This guidance does not cover the following types of products:
(...)
Medical devices
(...)
Click to expand...
Guidance on process validation for medical devices is provided in a separate document, Quality Management Systems – Process Validation, edition 2
Click to expand...
...which is this: http://www.imdrf.org/docs/ghtf/fina...g3-n99-10-2004-qms-process-guidance-04010.pdf

This process validation guidance is intended to assist manufacturers in understanding quality management system requirements concerning process validation and has general applicability to manufacturing (including servicing and installation) processes for medical devices. The guidance provides general suggestions on ways manufacturers may prepare for and carry out process validations.
Click to expand...
Please note that the FDA 2011 guidance is issued by CDER, CBER & CVM, so the pointer to the GHTF document doesn't necessarily represent CDRH's current stance on best guidance for Process Validation.

Cheers,
Ronen.
 
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