Role of QA in stability

Following the role of QA in stability testing.

-Review and Approval of stability protocol.

-Monitor the phases in developmental batches and to collect the sample as per stability plan.

-Specific sample size is charged in applicable storage condition for specific period.

-Review the results at regular time intervals of both Accelerated study, Controlled Room Temperature Study and any other condition.

  

- All results are filed accordingly in dossier as per regulatory requirement.

-What is the type of change and what are the stability conditions marked by regulatory department in its reporting category.

- Review and approval of stability protocol.

-Monitor the phases in commercial batches and to collect the sample as per stability plan.

 -Retention and destruction of stability sample

-Specific sample size is charged in applicable storage condition for specific period 

    

-Review the results at regular time intervals to verify that process is performing in its validated state.