ED Decision 2023/014/R
INVESTIGATION TEAM AND PROCEDURES
(a) The competent authority should appoint a production organisation investigation team for each applicant for a production organisation approval. This team is responsible for conducting all the relevant tasks related to the approval. The team should consist of a team leader to manage and lead the approval team and, if needed, one or more team members. The team leader should report to the manager who is responsible for the activities of the competent authority as defined in point 21.B.25(b).
(b) The competent authority should perform sufficient investigation activities for an applicant for a production organisation approval, to justify the recommendations for the issuance of the approval.
(c) The competent authority should prepare procedures for the investigation of a production organisation as part of the documented procedures that cover at least the following elements:
(1) evaluation of the application received;
(2) appointment of the investigation team;
(3) preparation and planning of the investigation;
(4) evaluation of the documentation (production organisation exposition, procedures, etc.);
(5) auditing;
(6) follow-up of corrective actions;
(7) recommendation for the issuance of a POA; and
(8) continued surveillance.
Loading collections...