GUIDELINES FOR STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS-GHANA

GHANA STABILITY GUIDELINES 

These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), replacing the previous FDA guidelines in this area . However, alternative approaches can be used when they are scientifically justified. It is recommended that these guidelines should also be applied to products that are already being marketed, with allowance for an appropriate transition period, e.g. upon re-registration or upon reevaluation.

These guidelines apply to new and existing APIs and address information to be submitted in original and subsequent applications for marketing authorization of their related FPP for human use. These guidelines are not applicable to stability testing for biologicals.

Ghana Stability Guidelines