Hi,
I was interested in knowing if there is an updated Stability Testing requirement for human drug products other than the one below dating back to 10/18/1985?
Expiration Dating and Stability Testing for Human Drug Products
My question is for medicated cosmetic drugs, is 1 lot per formula/size/1 year acceptable to retain reserve samples or should the finished product manufacturers be pulling more samples?
Any help would be appreciated.
Thank you.
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Zain Habib
Niles IL
United States
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