SCGT manages compliance through the diligent maintenance of a state of the art GMP process system for the manufacture of biological therapeutic goods. GMP establishes the framework of principles and procedures to be followed by manufacturers of therapeutic goods to ensure products meet the required regulatory standard and quality. With GMP standards providing the basis for manufacturing excellence, risk management controls the process to ensure all products are manufactured to the regulated standards for safety & efficacy.
SCGT has a permanent, on-site quality team within the facility managing the GMP processes applied to manufacturing while further developing critical elements such as environmental monitoring, continuous improvement, process control and facility validation. These elements are continually monitored through a robust internal audit program.
The quality team provides wide ranging support for manufacturing and clinical trials that are mandated under the relevant regulations
In Australia, biological therapies such as cellular therapies, gene therapies, blood, blood components, plasma derivatives, cell products and tissue products including their derivatives are regulated under the Therapeutic Goods Act 1989. Regulated by the Australian Government’s Therapeutics Goods Administration (TGA) biological therapies are under the umbrella of the Regulatory Framework for Biologicals that came into effect in June 2011.
The Australian Regulatory Guidelines for Biologicals (ARGB) provides information on the regulatory requirements for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as ‘biologicals’).
SCGT supports the provision and manufacture of biological therapies at all levels which is determined by the nature of the cellular or tissue product
For more information on:
What are therapeutic goods? Regulation of therapeutic cellular product; Good manufacturing practice, for therapeutic goods; Compliance with the GMP code and quality systems; SCGT and regulatory compliance, read more here.