Australia's Therapeutic Goods Administration (TGA)

Australia's Therapeutic Goods Administration (TGA) is the regulatory body responsible for safeguarding public health by ensuring the quality and safety of medicines and medical devices. For international pharmaceutical companies looking to export their products to the Australian market, undergoing and passing a TGA Good Manufacturing Practices (GMP) audit is a mandatory step.

A successful TGA audit provides the assurance that a manufacturer's facility and processes meet Australia's high quality standards.

The TGA Audit Process: Compliance and CAPA

The TGA's audit process is thorough, focusing on systematic adherence to quality standards.

Audit Execution: TGA auditors conduct an on-site inspection of the pharmaceutical company's facilities, focusing on all aspects of the manufacturing process, quality control, documentation, and personnel training.
Non-Compliance Listing: Following the audit, the TGA provides a list of non-compliances (deficiencies) identified during the inspection. These findings range in severity and must be addressed.
CAPA Response: The audited company must develop and submit a detailed Corrective and Preventive Action (CAPA) plan for each non-compliance. This plan explains what actions will be taken, how they will prevent recurrence, who is responsible, and the timeline for completion, aiming to satisfy the auditors that the facility will achieve sustained compliance.

📚 TGA GMP Guidelines: Your Compliance Roadmap

The TGA does not operate in a vacuum; its GMP standards are heavily influenced by international norms, particularly those of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). However, the TGA also publishes specific Australian Codes and Guides that manufacturers must follow:

TGA Guideline/Code	Focus Area	Relevance
Australian Code of GMP for Medicinal Products	The primary, comprehensive guide defining the minimum standards for the manufacture of therapeutic goods in Australia.	Essential for all finished product manufacturers.
PIC/S Guide for GMP for Medicinal Products	The internationally harmonized guide that forms the foundation of the TGA's expectations.	Provides the core structure and principles of the quality system.
Australian Code of GMP for Human Blood and Tissues	Specific requirements for facilities handling and processing blood, blood components, and human tissues.	Critical for manufacturers of biological products.
Guidelines for Sterility Testing of Therapeutic Goods	Detailed guidance on acceptable methods and practices for sterility assurance.	Mandatory for sterile product manufacturers.
PIC/S Explanatory Notes on Site Master File (SMF)	Guidance on how to prepare the Site Master File, a document describing the firm's GMP-related activities.	Required for facility documentation submission.
Guide to Interpretation of the Code of GMP for the manufacture of 18-Fludeoxyglucose injections	Example of a product-specific guide for unique, high-risk products (like radiopharmaceuticals).	Demonstrates the TGA's specialized compliance expectations.

Beyond Manufacturing: Wholesaling and IVDs

The TGA's quality scope extends beyond the factory floor to distribution and specialized product lines:

Australian Code of Good Wholesaling Practice: Covers the correct storage and distribution practices for medicines in various schedules (2, 3, 4, & 8), ensuring product quality is maintained throughout the supply chain.
IVDs (In Vitro Diagnostics): Separate guidance covers conformity assessment and declarations of conformity for diagnostic products, acknowledging their unique classification and risk profile.

For any pharmaceutical company aiming for the lucrative Australian market, treating the TGA audit as a partnership in quality, guided by their detailed codes and guidelines, is the only path to successful export.