ISO 13485 x ICH Q10 Pharmaceutical Quality System - Comparison Evaluation

Marcelo

Inactive Registered Visitor
#1
Has anyone here reviewed ICH Q10 in relation to ISO quality management system standards (9001 and 13485)?

I´ve reviewed Q10 some time ago and thought that they used some clever ways to put requirements, but didn´t perform a full comparison.

Someone commented about any possible enhancement to ISO 13485 that could come from Q10, and I wanted to know if someone here has already performed any assessment on this topic.
 
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Marcelo

Inactive Registered Visitor
#3
Yeah, Ajit, the discussion there does not address what I would need. I will need to revise Q10 in that way (looking for possible ways to use Q10 to help revise 13485) myself but will wait for more input.
 
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