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The guidance document [7] de nes signi cant change for drug product as one or more of the following: (1) a 5% change in assay from initial value or failure to meet the acceptance criteria for potency when using biological or immunological procedures; (2) any degradation product exceeding its acceptance criterion; (3) failure to meet the acceptance criteria for appearance, physical attributes, and functionality test (eg, color, phase separation, resuspendability, caking, hardness, and dose delivery per actuation; under accelerated storage conditions, some changes in physical attributes may be expected, eg, softening of suppositories and melting and possible phase separation in of creams); (4) failure to meet acceptance criterion for pH; and (5) failure to meet acceptance criteria for dissolution for 12 dosage units.

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If intermediate storage and testing become a necessity, a minimum of 6 months of data from this study should be submitted with the application The sampling frequency and testing in long-term stability studies should be targeted to generate data suf cient to establish a stability pro le of the drug product For long-term storage conditions, the guidance [7] recommends testing every 3 months over the rst year, 6 months over the second year, and annually thereafter through the proposed shelf life for drug products when the proposed shelf life is at least 12 months For a 6-month accelerated storage stability condition, sampling at 0, 3, and 6 months is recommended When signi cant changes to established test speci cations are likely to occur under the accelerated storage condition, increased testing is required with inclusion of a fourth sampling point.

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When signi cant changes to established test speci cations occur under the accelerated storage condition, testing at the intermediate storage condition for 12 months with sampling at time 0, 6, 9, and 12 is recommended Drug Products Packaged in Impermeable Containers For drug products packaged in impermeable containers that provide a permanent barrier, moisture or solvent loss is not a concern and for such products stability studies can be conducted under any controlled or ambient humidity conditions Drug Products Packaged in Semipermeable Containers Stability studies for aqueous-based drug products packaged in semipermeable containers (containers that allow the passage of solvent, usually water, while preventing solute loss) should be conducted under conditions of low relative humidity and temperatures speci ed in Table 2 Stability attributes such as potential water loss and physical, chemical, biological, and microbiological stability should be evaluated.

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