We are triying to fullfill EMA and FDA specifications for non viable count.
In the case of ISO 5 or Class A there are no match between both agencies.
USP, as the regulatory bibliography for FDA, declares that there is not a specified limit.
This limit should be justified and sustained by each company.
For EMA authorithies the limit is still ISO 14644, which allows <1 UFC/M3.
Could anyone tell me if one or another position is in better perspective to be adopted by the other?
Thanks a lot.
Cristian