CRED Getting the CMC Dossier Right 2024

05/09/2024

Stability of the Finished Product

Study conditions

Storage condition

Minimum data at time of submission

New API/DP Existing API/DP

Long-term * 25 ° C/60% RH or 30 ° C/65% RH 12 months

6 months

Intermediate 30 ° C/65% RH **

6 months

6 months

40 ° C/75% RH

Accelerated

6 months

6 months

* It is up to the applicant to decide whether to designate 25 or 30 as the long term condition ** Intermediate not required if accelerated data acceptable

Refrigerated product : 12 / 6 months at 5 ° C, 6 months at 25 ° C/60% RH

Product intended for Freezer : 12 months at -20 ° C.

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Stability of the Finished Product

• Stability protocol should only include parameters that could change during storage (e.g. assay, degradation products, not content uniformity)

• Store in the proposed commercial packaging

• Include in-use testing, reproducing the way a product will be used (containers being opened, some content removed and closed) throughout shelf life (minimum 2 batches) • Assess susceptibility to light both within and outside the packaging (ICH Q1B) • Bracketing and Matrixing possible to reduce amount of testing for multiple strengths and pack sizes (ICH Q1D) • Related: stress testing to confirm analytical methods are stability indicating (acid/alkali/oxidation/temperature)

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