Chapter 7 “Outsourced Activities” of the EU GMP Guidelines deals with the responsibilities of the contractor and contracting entity in the case of outsourced activities. Basically, the chapter states that all GMP processes and their supporting processes to be outsourced must be adequately defined, aggreed upon and controlled. The contractor and the contracting entity should have a written contract containing all respnsibilities and aggreements on with respect to the outsourced activities. The contracting entity is obliged to control the activities to be performed by the contractor. Moreover, he is responsible to safeguard that controlling processes exist for all outsourced activities. Prior to sourcing out, he must assess the adequacy and competence of the contractor. The GMP principles described in the guideline and their observance must be guaranteed by the contractor in the contract.
Accordingly, the contractor must perform the tasks assigned to him satisfactorily and fulfil his contractual obligations. Moreover, he is obliged to employ qualified personnel. It must be ensured on the contractor’s side the provided services, in this case, the computer-based systems, meet the specified requirements at all times and are adequate for the intended purpose. Unauthorized changes to activities or data are strictly prohibited. Outsourced activities as well as the agreed contract may be subject to inspection by the respective authority at any time. The contractor must be aware of this.