When is it necessary to perform in-use stability studies on solid oral dosage forms such as tablets and capsules in multi-dose containers? (H+V)

Data on the in-use stability of such products should be generated through a dedicated in-use stability study under long-term conditions when there is an indication from stability and/or stress studies that the drug product may be susceptible to deterioration. If there are no such indications, in-use stability studies do not need to be undertaken.

 

If an in-use study is required, what length is appropriate? (H+V)

The length of the in-use stability studies will be dependent on the intended use of the drug product. An in-use shelf life should only be set if necessary, i.e. when significant changes as defined in ICH Q1A (R2), or veterinary VICH GL3 as relevant, are observed. Read more

 

Can an open dish stability study be used to assess in-use stability? (H+V)

Yes. Storage without the protection of the immediate container is considered as a worst case scenario, and can in some instances be used to assess the need for an in-use shelf life. Read more