S.L. 437.108 Art. 8Premises and equipment.

(1) Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.

(2) Layout, design and operation must aim to minimize the risk of errors and 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 intended to be used for manufacturing operations which are critical for the quality of the products shall be subjected to appropriate qualification.