1.Where a manufacturing operation or operation linked thereto is outsourced, the outsourcing shall be the subject of a written contract.
2.The contract shall clearly lay down the responsibilities of each party. It shall lay down an obligation for the party to whom the operations are outsourced to follow good manufacturing practice and set out the manner in which the qualified person responsible for certifying each batch is to discharge his responsibilities.
3.The party to whom the operations are outsourced shall not subcontract any of the operations entrusted to him under the contract without written consent from the contract giver.
4.The party to whom the operations are outsourced shall comply with the principles and guidelines of good manufacturing practice applicable to the operations concerned and shall submit to inspections carried out by the competent authority pursuant to Article 63(4) of Regulation (EU) No 536/2014.