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 Consulting can conduct a truly independent Self-Inspections / Internal GMP Audit periodically on behalf of your Quality Management Team. We respect all types of systems implemented and provide assessment of your unique Quality Management System and will provide both cost-effective and compliant recommendations.

AXSource consultants will provide detailed audit report referencing documentation audited, regulatory requirements cited and your overall GMP compliance rating. Where required by client, we will support the development of any corrective actions & preventative actions (CAPA) to ensure GMP compliance of your QMS and either eliminate or mitigate risks prior to an impending regulatory inspection or Corporate Audit.

– 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