S.L. 437.108 Art. 10Production.

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

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

(3) Appropriate technical and, or organizational measures shall be taken to avoid cross contamination and mix-ups.

(4) Any new manufacture or important modification of a manufacturing process shall be validated.

(5) Critical phases of manufacturing process shall be regularly revalidated.