Manufacturing Date and Expiry Date – Qvents

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Updated on October 11, 2023

Updated on October 11, 2023

USFDA – Expiration Dates – Questions and Answers
USFDA Inspection Technical Guides: Expiration Dating and Stability Testing for Human Drug Products
European Medicines Agency (EMA): Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) – Scientific guideline.
EMA Note for Guidance on Start of Shelflife of the Finished Dosage Form
EMA – How should Expiry dates be calculated and expressed (EMA Quality of medicines questions and answers: Part 2)
WHO – Points to consider for setting the remaining shelf-life of medical products upon delivery (TRS 1044-Annexure 8 (WHO Technical Report Series)
WHO – DRAFT WORKING DOCUMENT FOR COMMENTS: Guidance on setting remaining shelf life for the supply and procurement of Emergency Health Kits

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