Qualification of premises and equipment
Article 19
1. Premises and equipment used in the manufacture of veterinary medicinal products, including utilities and systems, shall be qualified as appropriate to ensure that they are adequate for the intended operations. The qualification shall be performed in accordance with the requirements laid down in Annex V. 2. Decisions on the scope and extent of the qualification shall be based on a risk-assessment, which shall be documented. 3. Before starting the manufacture of a new type of veterinary medicinal product in premises that have already been qualified, the manufacturer shall assess if there is a need for re-qualification having regard to the specific risks and characteristics of the new manufacturing process or new product. 4. Premises and equipment shall be re-evaluated at appropriate intervals to confirm that they remain suitable for the intended operations.