Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 22

The automated machinery, electronic devices and computers used in the manufacture process or the related side software and equipment of drugs manufacture, manufacture, packaging or storage shall be periodically calibrated, checked and inspected under the existing plan and be filed for further maintenance.The major production and the management records controlled by the computer system must be maintained and may not be altered without the authorization of competent personnel. The accuracy of any input and print of all data shall be checked and the validation period concerned shall be determined by the complexity and the reliability of the computer system.