Calibration White Paper WORLD-CLASS CALIBRATION SOLLTONS™

BEAMEX Calibration White Paper Calibration in a regulatory environment In areas where instrument accuracy is critical to product quality or safety, for example in process industries such as chemicals and pharmaceuticals, calibration every six months – or even more frequently – is not unusual. In such industries rigid calibration schedules are necessary in order to maintain compliance. F or process manufacturers, regular calibration of instruments is common practice. In areas where instrument accuracy is critical to product quality or safety, for example in process industries such as chemicals...

BEAMEX Calibration White Paper laboratories where testing and/or calibration forms part of inspection and product certifications. Other regulations exist that are relevant to pharmaceuticals companies. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), for example, aims to improve harmonisation of Good Manufacturing Practice (GMP) standards and guidance documents. Other standards and regulations have emerged in response to the increased use of computerised systems for documenting inspection and calibration activities. GAMP, for example, is a Community...

BEAMEX Calibration White Paper Costly production downtime due to unforeseen instrument failures will also be reduced. The importance of documenting calibrations Calibrations must be traceable. Traceability is a declaration stating to which national standard a particular instrument has been compared. The organization itself determines the monitoring and measurements to be performed, as well as the measuring devices needed to provide evidence of a product’s conformity to determined standards. The organization also establishes the processes for ensuring that measurements and monitoring are carried...