TGA Regulations (Therapeutic Goods Administration) Framework
Sourced from: www.tga.gov.au

The TGA is a unit of the Australian Federal Department of Health and Ageing, and is responsible for administering a range of assessment and monitoring activities to ensure supplements are manufactured at a drug code level. Its standards are more stringent than the Food and Drug Administration (FDA).

Overall control of the supply of supplements is exercised through three main processes:

Pre-market assessment

All products are assessed for their level of risk to consumers, and are evaluated for quality, safety and efficacy. The strength of the product, side effects, potential harm from prolonged use, toxicity and seriousness of the condition for which the product is intended to be used are all taken into account.

Licensing of manufacturers

All manufacturers of therapeutic goods must be licensed. Their manufacturing processes must comply with principles of good manufacturing practice (GMP). GMP is used internationally to describe a set of principles and procedures which ensures any products manufactured meet a specific standard of quality for each batch of product, during all stages of the manufacturing process. Licensing standards protect public health by enforcing definable standards of quality assurance, and manufactured in conditions that are clean and free of contaminants.

Continued vigilance

All companies with a TGA license are subject to on-going inspections, equipment and batch testing to ensure the quality of products is consistent and up to standard. Any company registered with the TGA must meet specific requirements for:

• Quality management
• Personnel
• Premises and equipment
• Documentation
• Production
• Quality control
• Contract manufacture analysis
• Complaints
• Product recall
• Self-inspection

These requirements must be observed through all stages of the manufacture process in order to provide a high-level of assurance of product quality for the consumer. All reports of problems must be investigated, and lab testing of all products on the market must be conducted continuously to remain in compliance with legislation.

Regular On-site Audits

In order to ensure compliance with the TGA requirements, personnel conduct regular on-site audits. These audits assess the licensed facility is in compliance with manufacturing standards and all conditions specified in the manufacturing license, and to follow up with all consumer complaints. Each TGA audit includes:

• A detailed exam of operations and procedures of the factory
• Review of all processing activities
• Process validation
• Batch documentation
• Quality control testing of product samples

All manufacturers receive an audit summary, as well as a detailed report covering all aspects addressed in the audit. The audit remains open until a manufacturer responds satisfactorily to the contents. If gross negligence or major deficiencies are discovered, a manufacturer’s license may be suspended or revoked, or additional conditions may be added to the original license.