As a follow up on climatic testing I have a
question...when ICH Q1F was withdrawn there was a
statement made
"In assessing the impact of the withdrawal of ICH
Q1F on intermediate testing conditions defined in
ICH Q1A (R2), the decision was reached to retain
30°C/65%RH. However, regulatory authorities in
the ICH regions have agreed that the use of more
stringent humidity conditions such as 30°C/75% RH
will be acceptable should the applicant decide to
use them".
I just wonder...has anyone had problems with
regulatory authorities by having adopted the
65%RH even though they are operating in a
climatic zone III or IV?
Malcolm Ross
Generapharm-training and consultancy
Basel-CH
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