Other documentation
Article 23
1. Policies and procedures applied to safeguard the quality of the product shall be duly documented, including the following: (a) training; (b) validation of manufacturing process and relevant analytical methods; (c) qualification of premises and equipment (including utilities and systems); (d) procedures or instructions for the handling of materials and products; (e) release and rejection procedures for materials and products; (f) cleaning procedures and the validation thereof, which shall be in accordance with the requirements laid down in Annex V; (g) procedures relating to quality control; (h) maintenance and calibration of equipment; (i) environmental monitoring; (j) investigations into deviations and non-conformances; (k) procedures for handling of quality-related complaints and recall or return of products; (l) procedures for handling changes to the manufacturing process (change control); (m) internal audits as well as audits of suppliers and sub-contractors; (n) technology transfer, where applicable. 2. Clear operating procedures shall be available for main manufacturing and test equipment. 3. A site master file shall be prepared for every manufacturing site involved in the manufacture of veterinary medicinal products, which shall provide a high-level description of the premises, of the activities conducted at the manufacturing site and of the quality system implemented. A model template is set out in Annex VI.