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ONG Gamp 5 Awareness
Integrate the Computer System & Process with Gamp Controls :
Provide for Function Based Testing & Qualification, Tested with the equipment
& process.
At ONG we provide "Pre-FAT" qualification evidence with process simulation.
Check it once, but check it at the appropriate time, Develop the documents (Test
Plans) to fully support subsequent activities.
Use ONG Company Quality Systems / Industry Standards.
Avoid duplication of activities, e.g. by fully integrating engineering and computer
system activities and make sure they only happen.
Audit suppliers based on system risk / complexity / novelty, supplier assessments
are important. (i.e. postal can be used.).
Site audits on suppliers will always be justified on Risk and Project Cost Control
/ Rework.
Gamp 5 update : Rev : 1 Enforces when doing Risk Assessment, always assess the Probability
of Harm to the Patient / Customer if a fault occurs, rather than the probability
of the fault occurring.
Also assess the severity of the potential harm.
Increasing system complexity = increasing risk likelihood.
The basis of all risk assessment is intended to be the understanding of the business
process that are being assessed. .
GAMP 5 approach is consistent with ASTM E2500-07 Standard Guide for Specification,
Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems
and Equipment.
SUMMARY :
GAMP 5 is a step in the general alignment with industry over the use of Risk Based
Approach for qualification. The emphasis on system upgrades and changes to existing
systems rather than just considering major new builds is critical. At ONG we use
the following quality standards to mainiatin systems compliance. ISO 9001, ISO13485,
Gamp5.
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