Beijing medical device enterprise GMP inspection Glass instruments with scales (flasks, measuring cylinders, pipettes, etc.) need to be calibrated?

Must be calibrated, the calibration cycle (validity period) for glass measuring instruments is now three years, which is long enough.

If you want to calibrate in-house, you can do so, but the calibrator should have the necessary qualifications, which need to be authorized by the metrological verification department.

The document is based on the following, although there is no calibration personnel qualification content, but if the calibration is carried out if the personnel qualification personnel will be asked.

2010 version of the GMP:

Article 90 shall be in accordance with the operating procedures and calibration plan for the production and inspection of scales, gauges, meters, recording and control equipment and instruments for calibration and inspection, and to keep relevant records. The range of calibration shall cover the actual production and inspection of the scope of use.

Ninety-one shall ensure that key scales, gauges, meters, recording and control equipment and instruments used in production and inspection are calibrated, and the resulting data are accurate and reliable.

Article 92 should be calibrated using measurement standards, and the measurement standards should be used in accordance with relevant state regulations. Calibration records should be marked with the name of the measuring instruments used, number, calibration period and measurement of the certificate of conformity number to ensure the traceability of the records.

Article 93 of the scales, gauges, meters, equipment used for recording and control, and instruments should be clearly marked, indicating the validity of its calibration.

Article 94 shall not use uncalibrated, more than the validity of calibration, out of calibration scales, gauges, meters, and equipment and instruments for recording and control.