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AMC2 21.B.222(b) Oversight programme

ED Decision 2023/014/R

SUBCONTRACTED ACTIVITIES

If a production organisation subcontracts production activities, the competent authority should determine whether the subcontracted organisations need to be audited and include this in the oversight programme, taking into account the specific nature and complexity of the subcontracted activities, the results of previous oversight activities of the production organisation, and assessment of the associated risks.

For such an audit, the competent authority inspectors should ensure that they are accompanied throughout the audit by a representative of the production organisation.

NOTE: If a production organisation subcontracts production activities, the competent authority should verify that the production organisation has sufficient control over the subcontracted activities and manages the related risks.