The QP must be endorsed by the competent local authority according to the national law. There must be a written agreement between the QP and the manufacturer, clearly describing the role and responsibility. The permanent availability of the QP must be assured, the frequency of on-site availability and the way the QP gets all relevant information must be defined. The QP must be appropriately experienced in the manufacture and quality control of the product type manufactured by the contract giver. In case the products need additional formal education or experience – like with regard to blood products, the QP must comply with these requirements.
