What post-approval stability commitments are required?

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SFDA: “When the available long-term stability data on primary batches do not cover the proposed shelf-life granted at the time of approval, a commitment should be made to continue the stability studies post-approval to firmly establish the shelf-life.” (GCC v3.3 (archived) · 3.2.7 Stability commitment) “If the submission does not include stability data on production batches, a commitment should be made to place the first two or three production batches (see section 3.2.2) on long-term stability studies throughout the proposed shelf-life.” (GCC v3.3 (archived) · 3.2.7 Stability commitment) “Unless otherwise justified, at least one batch per year of product manufactured in every strength and every primary packaging type, if relevant, should be included in the stability programme (unless none is produced during that year).” (GCC v3.3 (archived) · 3.2.12 Ongoing stability studies) EU: “When available long term stability data on primary batches do not cover the proposed shelf life granted at the time of approval, a commitment should be made to continue the stability studies post approval in order to firmly establish the shelf life.” (ICH Q1A(R2) · 2.2.8 Stability Commitment) “If the submission includes data from stability studies on fewer than three production batches, a commitment should be made to continue the long term studies through the proposed shelf life and the accelerated studies for 6 months, and to place additional production batches, to a total of at least three, on long term stability studies through the proposed shelf life and on accelerated studies for 6 months.” (ICH Q1A(R2) · 2.2.8 Stability Commitment (item 2)) “If the submission does not include stability data on production batches, a commitment should be made to place the first three production batches on long term stability studies through the proposed shelf life and on accelerated studies for 6 months.” (ICH Q1A(R2) · 2.2.8 Stability Commitment (item 3)) US FDA: “When available long-term stability data on primary batches do not cover the proposed shelf life granted at the time of approval, a commitment should be made to continue the stability studies postapproval to firmly establish the shelf life.” (FDA Q1A(R2) · 2.2.8) “If the submission includes data from stability studies on fewer than three production batches, a commitment should be made to continue the long-term studies through the proposed shelf life and the accelerated studies for 6 months, and to place additional production batches, to a total of at least three, on long-term stability studies through the proposed shelf life and on accelerated studies for 6 months.” (FDA Q1A(R2) · 2.2.8) “Also, ANDAs and DMFs should include a commitment to place one batch of drug product and drug substance, respectively, into the annual long-term stability program, and to provide stability data in the annual reports.” (FDA ANDA stability Q&A 2014 · II.E, A7) WHO: “When the available long-term stability data on primary batches do not cover the proposed shelf life granted at the time of approval, a commitment should be made to continue the stability studies post-approval throughout the proposed shelf life. This is the primary batch stability commitment.” (WHO TRS 1010 Annex 10 · 2.2.8 Stability commitments) “If the submission includes data from stability studies on fewer than three production batches, a commitment should be made to place the next production batches, up to a total of at least three, on long-term stability studies throughout the proposed shelf life and on accelerated studies for six months. This is the production batch stability commitment.” (WHO TRS 1010 Annex 10 · 2.2.8 Stability commitments) “Unless otherwise justified, at least one batch per year of product manufactured in every strength and every primary packaging type, if relevant, should be included in the stability programme (unless none is produced during that year).” (WHO TRS 1010 Annex 10 · 2.2.13 Ongoing stability studies)

What post-approval stability commitments are 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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