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1.The Member States shall ensure that the manufacturers carry out the different production operations in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available by the manufacturer for the in-process controls. All process deviations and product defects shall be documented and thoroughly investigated.
2.The manufacturers shall be required to take appropriate technical and organisational measures to avoid cross contamination and mix-ups.
3.Any new manufacturing or important modification of a manufacturing process of a medicinal product shall be validated. Critical phases of manufacturing processes shall be regularly revalidated.