Description - Decision Tree for Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products

Tabulate and/or plot stability data on all attributes at all storage conditions and evaluate each attribute separately. Significant change at accelerated condition within 6 months? Yes, intended to be stored in a refrigerator? Yes, significant change at accelerated conditions within 3 months? Yes, no extrapolation; shorter retest period or shelf life and data covering excursions can be called for; statistical analysis if long-term data show variability. Yes, no extrapolation: shorter retest period or shelf life can be called for; statistical analysis if long-term data show variability. No, no extrapolation: shorter retest period or shelf life can be called for; statistical analysis if long-term data show variability.

Tabulate and/or plot stability data on all attributes at all storage conditions and evaluate each attribute separately. Significant change at accelerated condition within 6 months? Yes, intended to be stored in a refrigerator? No, significant change at intermediate. Yes, no extrapolation: shorter retest period or shelflife can be called for; statistical analysis if long-term data show variability. No, (1) long-term data amenable to statistical analysis and (2) statistical analysis? No to (1) or (2), if backed by relevant supporting data: Y = up to X + 3 months. Yes to both, if backed by statistical analysis and relevant supporting data: Y = up to 1.5X, but not exceeding X + 6 months.

Tabulate and/or plot stability data on all attributes at all storage conditions and evaluate each attribute separately. Significant change at accelerated condition within 6 months? No, long-term data show: (1) little or no change over time and (2) little or no variability? No to (1) or (2) or both, (1) long-term data amenable to statistical analysis and (2) statistical analysis performed? Yes to both, if backed by statistical analysis and relevant supporting data: Y = up to 2X, but not exceeding X + 12 months; or if refrigerated, Y = up to 1.5X, but not exceeding X + 6 months. No to (1) or (2), if backed by relevant supporting data: = up to 1.5X, but not exceeding X + 6 months; or if refrigerated, Y = up to X + 3 months.

Tabulate and/or plot stability data on all attributes at all storage conditions and evaluate each attribute separately. Significant change at accelerated condition within 6 months? No, long-term data show: (1) little or no change over time and (2) little or no variability? Yes to both, accelerated data show: (1) little or no change over time and (2) little or no variability? Yes to both, statistical analysis is normally unnecessary. Y = up to 2X, but not exceeding X + 12 months; or if refrigerated, Y = up to 1.5X, but not exceeding X = 6 months.

Tabulate and/or plot stability data on all attributes at all storage conditions and evaluate each attribute separately. Significant change at accelerated condition within 6 months? No, long-term data show: (1) little or no change over time and (2) little or no variability? No to (1) or (2) or both, (1) long-term data amenable to statistical analysis and (2) statistical analysis performed? No to (1) or (2), if backed by relevant supporting data: Y = up to 1.5X, but not exceeding X + 6 months; or if refrigerated, Y = up to X + 3 months.

Y = proposed retest period or shelflife
X = Period covered by long-term data