Calibration
Article 19
1. Manufacturers shall ensure that the following requirements are met: (a) control, weighing, measuring, monitoring and test equipment that is critical for ensuring the quality of the active substances or intermediates thereof is calibrated in accordance with written procedures and an established schedule; (b) equipment calibrations are performed using standards which ensure traceability to certified standards, where available; (c) records of the calibrations referred to in point (b) are kept; (d) the calibration status of equipment that is critical to the quality of the active substances or intermediates thereof is known and verifiable; (e) instruments that do not meet calibration criteria are not used. 2. Deviations from certified standards of calibration on critical equipment shall be investigated to determine the potential impact on the quality of the active substances or intermediates thereof manufactured using the concerned equipment since the last successful calibration.