... ICH Q1 stability guidelines. The ICH Q5C guideline gives general guidance on the expectations for the body of stability data needed to register biologics in ICH countries. It does not necessarily apply to such products as vaccines ...
Pharmaceutical Stability Testing to Support Global Markets
... India , for a country with a very diverse climate ? Was it 30 ° C / 65 % RH considering an average for whole of the country , or 30 ° C / 75 % RH taking into account WHO's Zone IVB option , or rather 30 ° C / 70 % RH considering actual ...
Analytical Testing for the Pharmaceutical GMP Laboratory
... USP <790> became official in August 2014. It is a nondestructive visual inspection of drug products looking for ... <1790> Visual Inspection in Injections became official with the intent of clarifying visual inspection processes to assist the ...
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