TGA: what is it & why do you need it?

The TGA, or Therapeutic Goods Administration, is the Australian Government’s medicine and therapeutical regulatory agency.

Operating under the Department of Health and Aged Care, it was formed in 1989 with the role to ensure all pharmaceuticals, medical devices and biological products supplied in Australia (whether produced here or abroad) meet strict regulations and are safe for human use and consumption.
The Therapeutic Goods Act 1989 requires all manufacturers of therapeutic goods in Australia, however large or small, to hold a licence or conformity assessment certificate to verify they are producing their products to TGA standards.

What Is a TGA-Approved Plant Room?

As the name suggests, a TGA-approved plant room refers to a manufacturing facility that has been certified by the TGA. This certification ensures the facility meets all relevant standards and regulations for the manufacturing of therapeutic goods.
The TGA has set out a range of elements that need to be carefully monitored and controlled to ensure the safe production of therapeutic goods. Some of these include:

• Designated location where both the design and layout of the facility remove the risk of errors and contamination
• Controlled environmental conditions such as temperature, humidity and air quality
• Smooth and easy-to-clean services that are deeply sanitised after every production run
• Protective clothing worn by all personnel entering the area with dedicated hand-washing facilities
• Access to a filtered water source.

At Nowchem Pharma & Skincare, we operate two TGA-approved plant rooms, known as ‘Theracells’. These carefully-separated rooms are highly contained to prevent external contaminants and toxins from entering the production process. With independent air conditioning, filtered water and designated cleaning areas, our state-of-the-art Theracell rooms are fully compliant with all TGA requirements.

Why Do We Need a TGA-Approved Plant Room?

Using a TGA-approved plant room is critical to meet the very specific standards that manufacturers must follow in line with Government regulations. It helps to ensure all therapeutic goods manufactured by/for your business are of the highest quality, free from contamination, inconsistencies and errors. Without one, your products could easily be subjected to a non-sterile production environment with potentially serious health impacts for your customers. It's also very important to remember, if TGA standards are not met, or maintained, you could risk losing your licence to operate.

Let’s Talk About Your Needs.

Nowchem Pharma & Skincare operates two TGA-approved plant rooms. Utilising them can help to ensure your products are continually produced within a safe, sterile environment while meeting all necessary standards for public health and safety.

Contact us today to learn more about how we can help you meet the strict manufacturing guidelines expected by the TGA.