Increasing transparency of Good Manufacturing Practice (GMP) inspection outcomes

The TGA is the Australian Government regulator responsible for the safety, quality and efficacy of therapeutic goods in Australia. The TGA’s regulatory functions include conducting inspections of manufacturing facilities, in Australia and internationally, to assess compliance with relevant manufacturing principles.

Good Manufacturing Practice Principles

The TGA applies manufacturing principles based on internationally harmonised GMP standards and includes:

• the Pharmaceutical Inspection Co‑operation Scheme (PIC/S) GMP Guide, which sets the mandatory manufacturing principles for all steps in the manufacture of medicines; and
• the Australian Code of GMP for human blood and blood components, human tissues and human cellular therapy products, which sets out the mandatory manufacturing principles for the collection, processing, testing, storage, release for supply and quality assurance of these products.

These principles help ensure pharmaceutical products are manufactured consistently and meet the required quality standards for their intended use. These principles cover areas such as:

• Quality management systems
• Personnel and training
• Premises and equipment
• Documentation and record keeping
• Production and process controls
• Quality control testing
• Packaging and labelling
• Release of products to the market.

GMP inspections

To assess compliance with GMP requirements, qualified TGA officers conduct inspections of manufacturing sites in Australia and internationally. Depending on risk and circumstances, inspections may be conducted at the manufacturing site, remotely, or using a hybrid approach.

Where non-compliance with GMP is identified during an inspection, manufacturers are required to address the findings through corrective and preventative action (CAPA) plans. Once all non-conformances are resolved and the TGA accepts the CAPA plans, the TGA issues a final inspection report with a compliance rating for the manufacturing site.

GMP inspections result in either an acceptable or unacceptable compliance rating. Where an unacceptable compliance rating is determined, the TGA may take additional regulatory actions.

For international manufacturing sites, the TGA will issue a GMP Certificate where an inspection confirms compliance with the same GMP requirements applicable to Australian sites. This certificate confirms compliance with GMP principles for a defined scope of manufacturing activities and for a specified period. GMP certificates are distinct from the manufacturing licence issued to manufacturing sites in Australia.

Transparency of GMP inspection outcomes

Providing information about regulatory activities is an important part of the TGA’s commitment to transparency. Making information about GMP compliance publicly available helps the public understand how manufacturers are regulated and supports confidence in the quality of medicines supplied in Australia.

The TGA currently publishes a list of domestic manufacturers that hold a GMP licence. The list on the TGA website includes the name of the manufacturer, the address and the approved manufacturing steps. However, unlike comparable international regulators, historically the TGA has not published lists of international manufacturers that have been inspected by the TGA. This information has been treated as confidential regulatory information and used primarily for regulatory purposes rather than public release. Similarly, the TGA has not published the outcomes of the inspections it conducts either within Australia or internationally.

The TGA is now proposing to publish the outcomes of all GMP inspections and the GMP certificates for international manufacturing sites. This is in response to increased public interest in regulatory transparency and to strengthen public confidence in the oversight of domestic and international manufacturing sites. The proposed approach is consistent with international regulatory practice. Publishing GMP certificates for international manufacturing sites would provide equivalent visibility to that currently available for Australian manufacturers.