In 2015/16, Seqirus combined two companies with a long history of protecting patient health. Now as one, we are starting our own legacy of patient safety and quality products. Our people, partners and suppliers are collaborating to create our own quality systems, which will deliver sustainable compliance and results.
In 2015/16, teams from across our organisation worked to create the Seqirus Quality Commitment manual and policies, setting management focus and a motivated environment of accountability. Our foundation in place, we continue to integrate our systems in a phased approach, aligning with the implementation of the supporting global electronic systems across the network. One example is the harmonisation of our supplier audit requirements across Seqirus, ensuring all of our suppliers continue to provide consistent high quality products and materials.
Ensuring product quality and safety starts before we manufacture a single product, by controlling and managing incoming materials and components. Control processes may include written specifications, supplier approval, supplier monitoring, receipt, testing/ release, storage, handling, distribution and supply chain integrity and security.
Seqirus' production facilities have appropriate process controls established at all stages of manufacturing to assure product quality. Sites must have procedures for sampling, testing, product approval or rejection, and the recording and storage of both product and process data. Processes and procedures are defined to ensure that product sterility is maintained, which includes controlling access to the manufacturing areas and controlling the environment itself.
We continue to monitor patient safety and product quality through our pharmacovigilance system, which facilitates the effective identification, assessment, monitoring and reporting of adverse events or safety information. This system helps Seqirus safeguard the health and safety of patients, consumers and clinical trial participants who are administered Seqirus marketed and investigational products.
On 15 July 2016, the Therapeutic Goods Administration approved AFLURIA QUAD™ for people aged 18 years and above in Australia. Manufactured in our Parkville facility, AFLURIA QUAD will replace our trivalent influenza vaccine (TIV), FLUVAX, in the 2017 Southern Hemisphere season. Our ultimate aim for AFLURIA QUAD is to achieve an age indication of six months and above, which was the indication held by the TIV formulation prior to the unexpected paediatric adverse events in 2010. A clinical program to support an age indication of 5–18 years was completed during the period with no safety concerns, paving the way for a study to be conducted in the 2016/17 Northern Hemisphere season.