S.L. 458.42 Art. 11Production.

(1)(a) The different production operations shall be carried out in accordance with pre-established instructions an d procedures and in accordance with good manufacturing practice.

(b) Adequate and sufficient resources shall be made available for the in-process controls.

(c) All process deviations and product defects shall be documented and thoroughly investigated.

(2) Appropriate technical or organisational measures shall be taken to avoid cross contamination and mix-ups.

(3) In the case of medicinal products, any new manufacture or important modification of a manufacturing process of a medicinal product shall be validated and the critical phases of manufacturing processes shall be regularly re-validated.