GAMP Good Automated Manufacturing Practices - Control System

Beamex ® CMX Calibration Software andGAMP - Good Automated Manufacturing Practices

GAMP Good Automated Manufacturing Practices• The GAMP Forum was established in 1991 to help promotethe understanding of how computer systems validation shouldbe carried out in the pharmaceutical industry.• Calibration is an essential element in ensuring compliance inthe pharmaceutical industry. To ensure success, calibrationshould be managed effectively by appropriately qualifiedpersonnel with good technical knowledge and practicalunderstanding. If neglected, calibration is capable ofcompromising both production and plant, and dramaticallyincreasing costs.

Key DefinitionsCalibration“The set of operations which establish, under specified conditions, the relationship betweenvalues indicated by a measuring instrument or measuring system, or values represented bya material measure, and the corresponding known values of a reference standard”.Validation“Action of providing, in accordance with the principles of Good Manufacturing Practices(GMP), that any procedure, process, equipment, material, activity or system actually leadsto the expected results”.Qualification“Action of proving that any equipment works correctly and actually leads to the expectedresults. The world ‘validation’ is sometimes widened to incorporate the concept ofqualification”.(Rules and Guidance for Pharmaceutical Manufacturers and Distributors, MAC, 1997)

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…

Key Regulatory Requirements6. All electronic systems used for calibration management for systems, which affectsproducts for supply to the USA must comply with the Food and Drug Administration(FDA) “21 CFR Part 11 – Electronic Records, Electronic Signatures”.8. Calibration measuring standards should be more accurate than the requiredaccuracy of the instrument that is being used.9. Each measuring standard should be traceable to a nationally, or internationally,recognized standard, where one exists.10. All instruments used should be fit for propose.11. There should be documented evidence that personnel involved in the calibrationprocess have been trained and are competent.12. A documented change management system should be established.

Back to MenuMaster History Record

Back to MenuAssign a Unique Instrument Number

Back to MenuApproved Procedure

Back to MenuCalibration Frequency

Back to MenuProcess Limits

Back to MenuThe Calibration Status

Back to MenuCalibration Records

Back to Menu21 CFR Part 11 – ER, ES• The FDA’s view is that the risk of falsification, misinterpretation, and change withoutleaving evidence are higher with electronic records than paper records, and thattherefore specific controls are required.Key Regulatory Requirements• Technology, System should allow applicable electronic data to be accessed inhuman readable form. System should be able to maintain applicable electronic dataover periods of many years.• Security, System should restrict use of system functions and features in accordancewith configurable rules that can be maintained. System should force to give uniqueelectronic signature when electronic record is created, modified or deleted.• Audit Trail, System should be able to identify changes to electronic record in orderto detect invalid or altered records.

Back to MenuStandard More Accurate than Instrument

Back to MenuStandard Should be Traceable

Back to MenuInstruments Used Should be Fit for Propose

Back to MenuPersonnel Trained and Competent

Back to MenuDocumented Change Management

Back to MenuAccessed in Human Readable Form

Back to MenuRestrict Use of System Functions

Back to MenuElectronic Signature

Back to MenuIdentify Changes to Electronic Record