An Annual Product Review (APR) must be conducted for each commercial product. The purpose of this SOP Template for an Annual Product Review is to verify the consistency of the process, to assess trends, to determine the need for changes in specifications, production, manufacturing, and/or control procedures and to evaluate the need for revalidation.
This SOP (template) applies to all products commercial manufactured on site. It includes all commercial Active Pharmaceutical Ingredients (API), Drug Product and Medical Devices Manufactured on site and for third parties used as contract manufacturer. Where semi-finished product is processed in multiple Sites, all Sites must participate in the Annual Product Review process by supplying information to the facility of release.
The Annual Product review provides the basis for deciding on the need to improve quality. The Annual Product Review must include all Batches of Product whether they were accepted or rejected and/or stability testing performed during the last 12 months period. The Annual Product Review 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 Annual Product Review must address the assessment of data, documents and electronic records reviewed.
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