Spring Intro 2023

28/03/2023

3.2.P Drug Product 3.2.P.8 Drug Product Stability

3.2.P.8.1Stability summary

– Details of batches tested (size, site & date) – Packaging details – Parameters tested – Methods used – Summary of major findings – Conclusions

3.2.P.8.2Stability commitment

3.2.P.8.3Stability data

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3.2.P Drug Product 3.2.P.8 Drug Product Stability

New applications: Drug Product (ICH)

Study

Storage Condition

Minimum data at time of submission

25 ° C + 2 ° C/60% RH + 5% RH, or 30 ° C + 2 ° C/65% RH + 5% RH

Long-term*

12 months

30 ° C + 2 ° C/65% RH + 5% RH

Intermediate

6 months

40 ° C + 2 ° C/75% RH + 5% RH

Accelerated

6 months

*It is up to the applicant to decide whether to designate 25ºC or 30ºC as the long-term condition ** If 30ºC is the long-term condition, intermediate not required

RH – Relative Humidity

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