International Inspections: TGA and the Management of GMP Compliance Signals

The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.

Unlike the FDA's Quality Metrics Program, companies are not expected to systematically report specific metrics to the agency. However, manufacturers (and also sponsors) are expected to report known or potential signals. In this regard, the TGA may also directly ask manufacturers and sponsors to submit, for example, inspection reports, evidence of corrective and preventive actions, and risk assessments. How to do this is described in the guidance. The TGA itself will draw on various internal and external sources of information and, of course, results from its own inspections.

In general, the data and lessons learned will be used to consider whether action should be taken and, if necessary, to assess the continued use of products on the Australian market if there have been certain negative GMP compliance signals. For this purpose, the TGA uses a four-point scale to classify risks from low to critical.

The document also lists examples that can be assessed as signals in addition to proprietary information. These include:

• Suspension of an EDQM Certificate of Suitability (CEP).
• Anonymous tip-off (whistleblowing)
• Warning Letter from the US FDA