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- The International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use guidance document Q1A (R2) (1) (ICH Q1A) defines shelf life as, “The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.”Publish Year: 2012DOI: 10.1208/s12249-012-9815-2Publication: AAPS PharmSciTech. 2012 Sep; 13(3): 911-918.Published: 2012/09www.ncbi.nlm.nih.gov/pmc/articles/PMC3429690/
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