Code of Good Manufacturing Practice (cGMP)

In addition to the pursuit of ISO Quality Management System, the BTS has sought to qualify the Code of Good Manufacturing Practice for Blood and Blood Components (cGMP) certification starting from 1997 as a further step to enhance the BTS’ Quality Management System.

 

In 2000, the BTS was successful in a compliance certification audit conducted by the Australian Therapeutic Goods Administration (TGA) for its cGMP accreditation with respect to its blood and components production. The major benefit of incorporating cGMP into the quality management system is that it ensures total process control and that, in turn, further enhances consistency in terms of blood safety and quality. This is an important step towards international benchmarking within the blood industry. It has also led to a defining cultural change within the BTS, making its management more accountable and the entire organization more open to change, self-assessment and objective in evaluation of performance.