Annual Product Review - APR

Annual Product Review minimum requirements

An Annual Product Review (APR) must be conducted for each commercial product. This document provides the basis for deciding on the need to improve quality. The APR must include all Batches of Product whether they were accepted or rejected and/or stability testing performed during the last 12 months period.

The APR must cover a one-year period, but does not have to coincide with the calendar year. The review must be completed within thirty (30) business days of the close of the period. A report for the Product Review must address the assessment of data, documents and electronic records reviewed.