Premises and equipment
Article 8
1. As regards the premises and manufacturing equipment the manufacturer shall be obliged to ensure that they are located, designed, constructed, adapted and maintained to suit the intended operations. 2. The Member States shall require that the premises and manufacturing equipment are laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product. 3. Premises and equipment to be used for manufacturing or import operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation.