1. Why do we have to perform the APR?

To evaluate the compliance status of the manufacture and identify the areas of the
improvements like production, packing and tests. Consistency of the process.
2. Who is the responsibility of the prepare the APR?
Whoever involved the manufacturing, but approval/release is QU.
3. if there is drift in the process capability, what next action?
Actions should be taken that to evaluate the causes and improve the performance in
forthcoming review.
4. how many contents are to be performed as per ICH Q7A.
6, those are, critical in-process control/parameters and final test results.
Review all specifications established. (OOS)
Deviations and non-conformances and related investigations.
Changes carryout in process and analytical methods.
Stability monitoring/holding study
Quality related recall, complaints and returns.
Review of adequacy of corrective actions.
5.