A sufficiently detailed quality agreement can help to avoid assumptions leading to conformity errors. While a quality agreement defines the specific quality parameters of a project and which parties are responsible for its execution, the degree of detail varies depending on the development phase of the project. In a quality agreement, the obligations and responsibilities of each party should be defined at least in the following basic elements: where a separate contract laboratory is involved, all relevant roles and responsibilities should be defined. The quality agreement should explicitly specify what data is shared and how it is disseminated. One of the unintended consequences of limiting the scope of the Guidelines is that the CDMs can use them as a pretext to limit the distribution of quality tasks up to the trade programme. This certainly makes the CDMO`s job easier, as they have to juggle the differences between each client`s QMS. The big question is: why would the Agency publish a guide that only deals with commercial manufacturing? The role of the order manufacturer has increased over the past decade and has expanded from API design to clinical logistics to pharmacovigilance. . . .