jag009
★★★

NJ,
2019-02-25 21:29

Posting: # 19971
Views: 2,928
 

 ISRs in Mexico and Brazil [Bioanalytics]

Hi,

Do we need ISRs for both Mexico and Brazil? I did a search on the net but so far not much concrete answers (for now).

Thanks
J
xtianbadillo
☆    

Mexico,
2019-11-21 02:31

@ jag009
Posting: # 20849
Views: 1,529
 

 ISRs in Mexico and Brazil

Regarding Mexico (NOM-177-SSA1-2013) Its not mandatory. But you can do if you want to according to "9.4.2.3 Cuando el reanálisis de un cierto número de muestras, se considere como parte del control del método analítico (When the reanalysis of a certain number of samples is considered as part of the control of the analytical method)."
hirenmistri
☆    

India,
2019-11-28 09:52

@ jag009
Posting: # 20880
Views: 981
 

 ISRs in Mexico and Brazil

Hi,

As such there's no brazil and mexico regulatory requirement to perform ISR, however, some clients insist to perform.
Activity
 Admin contact
20,641 posts in 4,327 threads, 1,437 registered users;
online 18 (1 registered, 17 guests [including 8 identified bots]).
Forum time: 10:50 CEST (Europe/Vienna)

I have had my results for a long time:
but I do not yet know how I am to arrive
at them.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5