When is an intermediate stability storage condition required?

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Accepted Answer

EU: “If long-term studies are conducted at 25°C ± 2°C/60% RH ± 5% RH and “significant change” occurs at any time during 6 months’ testing at the accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria. The initial application should include a minimum of 6 months’ data from a 12-month study at the intermediate storage condition.” (ICH Q1A(R2) · 2.2.7.1 General case) “Intermediate** 30°C ± 2°C/65% RH ± 5% RH 6 months” (ICH Q1A(R2) · 2.2.7.1 General case (table)) “Studies conducted at 30°C/65% RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25°C.” (ICH Q1A(R2) · 3. Glossary – Intermediate testing) US FDA: “Intermediate** 30°C ± 2°C/65% RH ± 5% RH 6 months” (FDA Q1A(R2) · 2.2.7.1 (table)) “If 30°C ± 2°C/65% RH ± 5% RH is the long-term condition, there is no intermediate condition.” (FDA Q1A(R2) · 2.2.7.1 (table footnote **)) “If long-term studies are condcuted [sic] at 25°C ± 2°C/60% RH ± 5% RH and significant change occurs at any time during 6 months’ testing at the accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria.  The initial application should include a minimum of 6 months’ data from a 12-month study at the intermediate storage condition.” (FDA Q1A(R2) · 2.2.7.1) WHO: “Intermediateᵇ 30 °C ± 2 °C/65% RH ± 5% RH 6 months” (WHO TRS 1010 Annex 10 · 2.2.7.1 General case (table)) “If long-term studies are conducted at 25 °C ± 2 °C/60% RH ± 5% RH and “significant change” occurs at any time during 6 months’ testing at the accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria. In this case the initial application should include a minimum of six months’ data from a 12-month study at the intermediate storage condition.” (WHO TRS 1010 Annex 10 · 2.2.7.1 General case) “If 30 °C ± 2 °C/65% RH ± 5% RH or 30 °C ± 2 °C/75% RH ± 5% RH is the long-term condition, there is no intermediate condition.” (WHO TRS 1010 Annex 10 · 2.2.7.1 General case, table footnote b)

When is an intermediate stability storage condition required?

SFDA Saudi Food and Drug Authority

EU European Union

US FDA US Food and Drug Administration

WHO World Health Organization

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