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AMC1 21.B.221 Oversight principles

ED Decision 2023/014/R

OVERSIGHT TEAM AND PROCEDURES

(a) The competent authority should appoint a production organisation oversight team for each holder of 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 oversight 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 pointย 21.B.25(b).

(b) The competent authority should perform sufficient oversight activities for the holder of a production organisation approval, to justify the recommendations for the maintenance, amendment, limitation, suspension or revocation of the approval.

(c) The competent authority should prepare procedures for the oversight of a production organisation as part of the documented procedures that cover at least the following elements:

(1) appointment of the production organisation oversight team;

(2) review of result of past oversight activities;

(3) appointment of the production organisation oversight team;

(4) preparation and planning of the oversight;

(5) evaluation of the documentation (production organisation exposition, procedures, etc.)

(6) auditing;

(7) follow-up of corrective actions;

(8) recommendation for the amendment, limitation, suspension or revocation of a production organisation approval; and

(9) continued surveillance.