Commission Directive 91/412/EEC of 23 July 1991 laying down… Article 10

Article 10

Production The different production operations shall be carried out according to pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available for the in-process controls. Appropriate technical and/or organizational measures shall be taken to avoid cross contamination and mix-ups. Any new manufacture or important modification of a manufacturing process shall be validated. Critical phases of manufacturing process shall be regularly revalidated.