The European Medicines Agency (EMA) has developed guidelines for the stability testing of drug substances and products, including pharmaceutical vaccines. These guidelines are designed to assist medicine developers in obtaining marketing approval and ensuring the quality and stability of pharmaceutical products over time. The EMA's guidance includes recommended tests for in-use studies and delineates the necessary stability testing requirements for a minimum of 6 months under long-term and accelerated conditions.

The guidelines outline the core stability data package required for registration, including storage conditions, sampling plan, and testing frequency, which are based on Directive and Regulation requirements in the European Community for human pharmaceuticals. Additionally, the EMA mandates product-specific storage stability testing for herbal medicinal products, following these guidelines.

For further details and specific references, I recommend accessing the official EMA guidelines for stability testing of pharmaceutical products, which provide comprehensive information tailored to the pharmaceutical industry's specific requirements.

Sources

Quality: stability | European Medicines Agency[PDF] Stability Testing of existing active substances and related finished products - European Medicines AgencyIn-Use Stability Studies for Multi-Dose Products (Part 1: EMA) - StabilityHub[PDF] Annex 5 Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage formsNew EMA Guideline on Stability Testing for Applications for Variations - ECA AcademyRegulatory aspects of stability testing in Europe - PubMed

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