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Most of our medicines are derived from a human-sourced raw material – human plasma – and it is essential that we have robust, compliant and fully traceable processes throughout the entire production. Each year Octapharma handles 5.6 million litres of plasma collected by 300 plasma suppliers.
Our goal in CQP is to ensure regulatory compliance of all our external and internal processes, from the point of collection at our plasma suppliers until the plasma is released for production. My group’s responsibilities include auditing and qualifying Octapharma’s plasma-related suppliers and maintaining our Plasma Master File (PMF), which is the compilation of all the required scientific and regulatory data on the quality and safety of human plasma. In 2016 we established Octapharma’s CQP function, which is responsible for all plasma-related quality activities. Previously the function was set up with local quality assurance plasma departments reporting into the local quality units. The corporate approach now allows possibilities for more harmonisation of our internal processes across all sites.
We have a clear understanding of the requirements dictated by regulations as well as our business needs, and we must communicate these effectively to our suppliers, which include plasma donation centres, blood banks, testing laboratories, transport companies and warehouses as well as our internal partners.
We conduct regular audits of about 500 suppliers to ensure they are working according to the mandated procedures and regulations. When we are auditing a plasma supplier we always try to include the processes for a completely new first time donor. We follow the entire donor flow from the moment the donor first registers, right through to when they leave the centre. We also look at the relationship between the staff and donors by observing how the donor centre staff behave towards the donor.
Our patients depend on us doing our job in the best possible and compliant way. Good manufacturing practice (GMP) is the world my team and I live in. These are the regulations that we follow to be compliant. As employees, we all have a responsibility to raise our hands if we recognise that something is not done in the right way. We have a duty to our patients.
Some countries have restrictions on plasma origin for their final products; therefore we must ensure that these products are made from the correct plasma source. This is ensured through robust traceability systems. If a plasma supplier is located outside of Europe and we want to use that plasma for European products, we need to ensure the supplier is approved by a European authority. For that reason we work very closely with the Austrian Agency for Health and Food Safety (AGES), which carries out the inspections in our US plasma donation centres.
Our objective in CQP is to sustain the high level of quality we have built up in correlation with our plasma suppliers in our internal processes, to ensure safety and tolerability for products and patients. Our patients cannot visit our manufacturing sites or our donor centres personally, so they rely on us. I am proud to know that my group and I are playing this important part in fulfilling our responsibility to our patients.