Eudralex Quality Agreements

PTE: What is the responsibility of a pharmaceutical company to guarantee the quality and safety of products or ingredients manufactured in a contract establishment? Iser: Although a pharmaceutical company (or an application sponsor or marketing authorisation holder) is ultimately responsible for ensuring that the products available to patients and nurses meet quality and safety expectations, ensuring the quality and safety of the products and ingredients produced in a contract establishment is a shared responsibility between the pharmaceutical company and everyone. of them. approved establishment. . . .

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