Which label storage statement corresponds to the tested storage condition?

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Accepted Answer

SFDA: “30 °C/65% RH (long-term) 40 °C/75% RH (accelerated) “Do not store above 30 °C”” (GCC v3.3 (archived) · Appendix 2, Table 2 (FPPs)) “5 °C ± 3 °C ”Store in a refrigerator (2 °C to 8 °C)” -20 °C ± 5 °C “Store in freezer”” (GCC v3.3 (archived) · Appendix 2, Table 2 (FPPs)) ““Protect from moisture” should be added as applicable.” (GCC v3.3 (archived) · Appendix 2, Table 2 (footnote b)) EU: “25°C/60%RH (long term) 40°C/75%RH (accelerated) or 30°C/65%RH (long term) 40°C/75%RH (accelerated) None*** Do not refrigerate or freeze” (EMA storage declaration · A. 4. Core storage statements (table)) “25°C/60%RH (long term) 30°C/60 or 65%RH (intermediate) or 30°C/65%RH (long term) Do not store above 30°C or Store below 30°C Do not refrigerate or freeze” (EMA storage declaration · A. 4. Core storage statements (table)) “25°C/60%RH (long term) Do not store above 25°C or Store below 25°C Do not refrigerate or freeze” (EMA storage declaration · A. 4. Core storage statements (table)) US FDA: “A storage statement should be established for the labeling in accordance with relevant national/regional requirements.  The statement should be based on the stability evaluation of the drug product.” (FDA Q1A(R2) · 2.2.10) “Where applicable, specific instruction should be provided, particularly for drug products that cannot tolerate freezing.  Terms such as ambient conditions or room temperature should be avoided.” (FDA Q1A(R2) · 2.2.10) “There should be a direct link between the label storage statement and the demonstrated stability of the drug product.” (FDA Q1A(R2) · 2.2.10) WHO: “Testing condition under which the stability of the FPP has been demonstrated Recommended labelling statementᵃ 25 °C/60% RH (long-term) 40 °C/75% RH (accelerated) “Do not store above 25 °C” 25 °C/60% RH (long-term) 30 °C/65% RH (intermediate, failure during accelerated stability studies) “Do not store above 25 °C”ᵇ 30 °C/65% RH (long-term) 40 °C/75% RH (accelerated) “Do not store above 30 °C”ᵇ 30 °C/75% RH (long-term) 40 °C/75% RH (accelerated) “Do not store above 30 °C”” (WHO TRS 1010 Annex 10 · Appendix 2, Table A10.2 Recommended labelling statements for finished pharmaceutical products) ““Protect from moisture” should be added as applicable.” (WHO TRS 1010 Annex 10 · Appendix 2, Table A10.2, footnote b) “Demonstrated stability at zone II conditions may result in a label storage statement of “Store between 15 and 30 °C” in line with the convention of some zone II regions. A product with such a statement, received in a zone IV country, would be expected to have demonstrated stability at zone IVa or IVb long-term stability conditions. However, when the stability was demonstrated at zone II long-term conditions, the appropriate statement for distribution in a zone IV region would be “Do not store above 25 °C”.” (WHO TRS 1010 Annex 10 · Appendix 3 Interpretation of storage statements for products approved in climatic zone II when the products are to be distributed in zone IV)

Which label storage statement corresponds to the tested storage condition?

SFDA Saudi Food and Drug Authority

EU European Union

US FDA US Food and Drug Administration

WHO World Health Organization

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