Quality agreement

A written agreement between a client and a contract manufacturer or laboratory that divides quality responsibilities: who releases, who handles deviations, who approves changes and how quickly each side must inform the other. Japanese regulations use a different word for it, a written arrangement (取決め). The GQP Ordinance requires the marketing authorization holder to have one with each manufacturer (Article 7, contract with manufacturers), and the 2021 revision of the GMP Ministerial Ordinance added an article on managing outsourced contractors (Article 11-5). Japanese clients often want deadlines for reporting deviations and changes written in, because the MAH must decide quickly whether a regulatory filing is needed.