Quality management and regulation
What are therapeutic goods?
Therapeutic goods are any products that are used in healthcare to treat, prevent or diagnose diseases, ailments, defects or injuries (therapeutic use). Since the introduction of the Biologicals Regulatory Framework in June 2011. Biologicals are defined as products made from or containing human cells or human tissues.
Regulation of therapeutic cellular products
In Australia biological therapies, such as cellular and gene therapies, blood, blood components, plasma derivatives and cell and tissue products and their derivatives are regulated under the Therapeutic Goods Act 1989. Regulation is overseen by the Australian Government’s Therapeutics Goods Administration (TGA).
Some blood and tissue products are exempt from TGA oversight, but other products must be manufactured to comply with the Australian Code of GMP for Human Blood and Tissues.
Regulations developed under the Therapeutic Goods Act 1989 (and all the subsequent amendments to the Act) govern the extent to which approval must be sought and obtained from the TGA prior to use in the treatment of patients. Information regarding the classification of different biologicals and their relevant regulation can be found in the Australian Regulatory Guidelines for Biologicals (ARGB). www.tga.gov.au/industry/biologicals-argb.htm.
Biologicals are classified into one of four classes, based on the extent to which the initial cells or tissues are manipulated, or have their normal biological function modified for therapeutic use. The level of regulatory oversight increases with each Class (1 to 4), with increasing requirements for the provision of information and data to enable safety and efficacy evaluation by the TGA for registration of the product on the Australian Register of Therapeutic Goods (ARTG).
The highest level of oversight that can be applied to the production of a biological therapeutic good is manufacture under Good Manufacturing Practice (GMP) compliance, which must be undertaken under a TGA manufacturing licence or clearance.
In some circumstances, for example, for the use of a cellular product in a Phase I trial, biologicals can be supplied as an un-approved therapeutic good. The mechanisms by which this can occur are described in the Australian Regulatory Guidelines for Biologicals (ARGB). http://www.tga.gov.au/industry/biologicals-argb.htm
Good manufacturing practice for therapeutic goods
What is GMP?
Good Manufacturing Practice (GMP) is the set of principles and procedures to be followed by manufacturers of therapeutic goods to ensure the manufactured products meet the required quality. If the manufacture of a biological product requires compliance to GMP, the facility in which the good is manufactured must support adherence to GMP principles and procedures. One particular requirement of adherence to GMP is the establishment of a robust quality system to underpin all activities within the facility, including product specific manufacturing processes.
Compliance with the GMP code and quality systems
How is compliance with GMP determined?
Compliance with the Code of GMP is determined through an on-site audit by the TGA. Such audits evaluate the quality system in place to support GMP activity, and also assess compliance with any relevant manufacturing standards.
How is GMP audited?
Each audit involves a detailed examination of the operations and procedures of the facility, and includes a detailed review of all processing activities, process validation, batch documentation and quality control testing.
SCGT and regulatory compliance
The facilities within SCGT are designed and maintained utilising GMP manufacturing principles. Processing within the SCGT is managed to meet the requirements Biologicals Framework. The aim of the SCGT Quality Team is to provide a quality system that fully supports GMP manufacturing.