Pharmacy Courses

Post-approval and On-going Stability Commitment

Post-approval Stability Commitment

A commitment which is submitted to authority, when the available long-term stability data on primary batches do not cover the proposed shelf-life period granted at the time of assessment of the dossier.

Ongoing Stability Commitment

The stability of the drug product should be monitored over its shelf-life to determine that the product remains within its specifications and to detect any stability issue (e.g. changes in levels of degradation products). For this purpose, the ongoing stability programme should include at least one production batch per year of product manufactured in every strength and every container closure system (unless none is produced during that year). This commitment letter is known as ongoing stability commitment.

Read also:

Previous Post Next Post