Appointed as authorized person (AP) to certify product release and ensuring that each batch has been manufactured and checked in compliance with national requirements, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP) upon completion of AP qualification. The AP who performs certification of the finished product batch will assume full responsibility for all stages of manufacture of the batch or this responsibility may be shared with other AP who have provided confirmation for specified steps in the manufacture and control of a batch.
Product Approval and Release: ensure well planned and timely execution on BMR/CoA/Analytical Report review, approval and system releases.
To support in preparation of the annual product quality review and implement on-going verification of product performance, ensure annual product quality review is carried out with trending ana...