Risk based approach to audit frequency

The Office of Manufacturing Quality is responsible for the ongoing assessment of manufacturers’ compliance with Codes of Good Manufacturing Practice (GMP).

On-site audits are conducted as the most direct method of assessing a manufacturer’s compliance with GMP and form the cornerstone of regulatory programs worldwide.

It is common for a manufacturer’s product range, key staff, equipment, premises, procedures, financial status, etc to change over time. As these have the potential to impact on GMP compliance, manufacturers are audited on a regular basis to verify continued compliance with manufacturing standards.

The TGA has established a risk based approach to guide the scheduling of audits based on the compliance history of the manufacturer, the products made and the manufacturing processes undertaken.

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