Have you ever wondered how the expiration date is determined for a pharmaceutical product you’ve used? Whether prescription or over the counter, all medications have their expiration dates determined through a stability program in which batches of the product are held at the recommended long-term storage conditions and tested at regular intervals. The expiration date ((or shelf life) of the product is determined by the length of time the product remains effective for use. Both the drug product and the drug substance are subject to stability testing requirements, which are covered for most countries in ICH Q1A, Stability of New Drug Substances and Products. The Q1 series (A-F) covers all of the requirements for establishing the stability of drug substance and product and verifying that shelf life over time, and cross references other ICH guidance such as The Q3 series for impurities or Q6 for specifications as appropriate. Biotechnology product stability is covered under Q5C, Stability Testing of Biotechnological/Biological Products.
Reach out to me if you want to know more or discuss your medical product development challenges.
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