Requirements for outsourced activities
Article 66
1. The outsourcing of operations related to the manufacturing or control of active substances shall be made by means of a written contract that provides for clear delineation of the responsibilities of each party. 2. The following additional aspects shall be covered in the contract: (a) the contract acceptor shall comply with good manufacturing practice for active substances; (b) the contract acceptor shall permit audits by the contract giver in connection with the outsourced activities; (c) all records related to the outsourced activities shall be kept at the site where the activity occurs and be easily accessible; (d) the contract acceptor shall not subcontract any of the work entrusted to him or her under the contract without written authorisation from the contract giver; (e) the contract acceptor shall not make changes in the process, equipment, test methods, specifications or other contractual requirements without written authorisation from the contract giver. 3. All outsourced manufacturing or control operations shall comply with the good manufacturing practices for active substances used as starting materials in veterinary medicinal products. Special consideration shall be given to prevent cross-contamination and to ensure traceability. 4. Contract acceptors shall be audited by the contract giver to ensure compliance with good manufacturing practices for active substances used as starting materials in veterinary medicinal products as regards the specific operations occurring at the contract sites.