Pharmaceutical Good Manufacturing Practice Regulations Article 112

Manufacturers shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.Manufacturers shall establish documented procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.Where necessary to ensure valid results, measuring equipment shall conform to the following:(1) Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;(2) Be adjusted or re-adjusted as necessary;(3) Be identified to enable the calibration status to be determined;(4) Be safeguarded from adjustments that would invalidate the measurement result;(5) Be protected from damage and deterioration during handling, maintenance and storage.In addition, manufacturers shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. Manufacturers shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained.When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.