Implementing Quality Agreements at the Contract Laboratory | IVT

INTRODUCTION A contract research organization (CRO) providing experimental testing services under current good manufacturing practices (cGMP) can expect to enter into numerous quality agreements (QAG) with pharmaceutical industry clients (sponsors). These agreements, usually initiated by the client, are intended to ensure that the CRO addresses key client concerns according to client requirements. For example, concerns may include issues such as timely client notification for a confirmed out-of-specification (OOS) result. More generally, the CRO must support promises made by the client to a regulatory...