GAMP Good Automated Manufacturing Practices - Control System

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ResponsibilitiesProcess OwnersTo identify the critical parameters, the processvariables, and to derive acceptable limits.Quality Assurance (QA)To verify the limits are acceptable and ensurethat parameters meet regulatory compliance.EngineeringTo propose the use of suitable instrumentationand asses whether instruments are fit forpropose.
Key Regulatory Requirements1. Each instrument should have a permanent master history record.2. All instrumentation should be assigned a unique number and all product, process,and safety critical instruments should be physically tagged.3. The calibration method should be defined by approved procedure.4. Calibration frequency and process limits should be defined for each instrument.5. There should be a means of readily determining the calibration status of eachinstrument.6. Calibration records should be maintained.Continue…
Page 1 and 2: Beamex ® CMX Calibration Software
Page 3: Key DefinitionsCalibration“The se
Page 7 and 8: Back to MenuMaster History Record
Page 9 and 10: Back to MenuApproved Procedure
Page 11 and 12: Back to MenuProcess Limits
Page 13 and 14: Back to MenuCalibration Records
Page 15 and 16: Back to MenuStandard More Accurate
Page 17 and 18: Back to MenuInstruments Used Should
Page 19 and 20: Back to MenuDocumented Change Manag
Page 21 and 22: Back to MenuRestrict Use of System
Page 23: Back to MenuIdentify Changes to Ele

GAMP Good Automated Manufacturing Practices - Control System

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