Article 12
Work contracted out 1. Any manufacturing operation or operation linked with the manufacture which is carried out under contract, shall be the subject of a written contract between the contract giver and the contract acceptor. 2. The contract shall clearly define the responsibilities of each party and in particular the observance of good manufacturing practice by the contract acceptor and the manner in which the qualified person responsible for releasing each batch shall undertake his full responsibilities 3. The contract acceptor shall not further sub-contract any of the work entrusted to him by the contract giver without the written authorization of the contract giver. 4. The contract acceptor shall respect the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities as provided for by Article 34 of Directive 81/851/EEC.