ONG Gamp 5 Awareness

At ONG we provide "Pre-FAT" qualification evidence along with Code Reviews and process simulation.

Check it once, but check it at the appropriate time in the product life-cycle is ONG's philosophy. Develop the documents (Test Plans) to fully support subsequent activities.

At ONG we use the Company Quality Systems / Industry Standards to avoid duplication of activities by fully integrating engineering and computer activities.

Using GAMP guidelines ONG audits suppliers based on system risk / complexity, supplier assessments are important. (i.e. postal audit can be used.) Site audits on suppliers will always be justified on Risk and Project Cost, Rework and approving the AVL (Approve Vendor List) each year.

Gamp 5 update on Risk Assessment:

Rev : 1 Enforces when doing Risk Assessment, always assess the Probability Harm to the Patient / Customer if a fault occurs.
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.