How often must stability samples be tested?

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SFDA: “For products with a proposed shelf-life of at least 12 months, the frequency of testing at the long-term storage condition should normally be every three months over the first year, every six months over the second year and annually thereafter throughout the proposed shelf-life (e.g., 0, 3, 6, 9, 12, 18, 24, 36 months).” (GCC v3.3 (archived) · 3.2.5 Testing frequency) “At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g. 0, 3 and 6 months), from a six-month study is recommended.” (GCC v3.3 (archived) · 3.2.5 Testing frequency) EU: “For products with a proposed shelf life of at least 12 months, the frequency of testing at the long term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed shelf life.” (ICH Q1A(R2) · 2.2.6 Testing Frequency) “At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended.” (ICH Q1A(R2) · 2.2.6 Testing Frequency) US FDA: “For products with a proposed shelf life of at least 12 months, the frequency of testing at the long-term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed shelf life.” (FDA Q1A(R2) · 2.2.6) “At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended.” (FDA Q1A(R2) · 2.2.6) “When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum of four time points, including the initial and final time points (e.g., 0, 6, 9, 12 months), from a 12-month study is recommended.” (FDA Q1A(R2) · 2.2.6) WHO: “For products with a proposed shelf life of at least 12 months, the frequency of testing at the long-term storage condition should normally be every three months over the first year, every six months over the second year and annually thereafter throughout the proposed shelf life.” (WHO TRS 1010 Annex 10 · 2.2.6 Testing frequency) “At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g. 0, 3 and 6 months), from a six-month study is recommended.” (WHO TRS 1010 Annex 10 · 2.2.6 Testing frequency) “When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum of four time points, including the initial and final time points (e.g. 0, 6, 9 and 12 months), from a 12-month study is recommended.” (WHO TRS 1010 Annex 10 · 2.2.6 Testing frequency)

How often must stability samples be tested?

SFDA Saudi Food and Drug Authority

EU European Union

US FDA US Food and Drug Administration

WHO World Health Organization

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