Quality

In accordance with its own exacting standards and those required by the TGA, GD Pharma has built policies and procedures into all aspects of its operation, including Quality Risk Management as an integral part of the Quality Management System. Sponsors and clients can be confident that quality assurance provides a back-stop of excellence in all their projects.

At GD Pharma, we develop and maintain high quality documentation in compliance with the latest PIC/S Guide to Good Manufacturing Practice for Medicinal Products. As part of our commitment to quality, we conduct internal and external audits regularly to ensure cGMP compliance of both ourselves and our suppliers, and monitor any corrective action(s) taken. We are also happy to host GMP Inspections by clients. Our facilities undergo constant monitoring by our quality team, including environmental monitoring of all cleanrooms, ensuring all stages of production are performed in a controlled environment.

TGA Manufacture

Our licenses

GD Pharma holds a current TGA Licence to manufacture Therapeutic Goods. This license covers a variety of both terminally sterilised and non-sterile liquid preparations for Clinical Trials and Registered Therapeutic Goods. These include nasal drops, oral liquids, eye drops and injections. We also possess a current Manufacturer’s Licence through the Controlled Substances Act, 1984 to manufacture Controlled Substance medications.

Controlled Substance Manufacture

TGA Manufacture

GMP Certificate

Need a custom order?