Regulatory Inspections

Regulatory Inspections under GMP, GLP, GCP, GVP, GDP, GPP, or GACP Guidance

AXSource Consulting emerges as a partner of choice in managing the lifecycle from development of quality management systems to preparing and hosting your facility for Regulatory Inspections. Allow us to ensure a successful outcome of your facility by:

– Conducting detailed site audit to ascertain company’s overall compliance status, and identify potential non-conformances.
– Providing necessary guidance to implement corrective action in time for inspection
– Providing training on how to host an inspection and minimize cost
– Hosting your Regulatory Inspection with your staff to mitigate any financial /compliance risks
– Leading negotiations and presentation of credible evidence to support any non-conformances communicated
– Providing strategic, cost-effective and timely Remedial Action Plan to the relevant Agency (Warning Letter, Form FDA 483, EIR, Inspection Notice etc.)

Ensuring complete close-out of inspection process with company staff

AXSource Consulting has performed Third Party Audits for:

Regulatory Inspection

AXSource periodically can conduct Self Inspections on behalf of Quality Management to:AXSource provides detailed reports reflecting third party documentation and GMP compliance and can establish corrective/preventative actions (CAPA) to ensure GMP compliance.

– Independently review company’s conformance to approved internal quality systems and current regulations and Guidance(s)
– Document the Self-Inspection report in order to address any deviations
– Establishing a CAPA management process and final disposition of observations
– Implement revisions to Quality Systems to ensure increased efficiency and accuracy
– Follow up until self-inspection close-out