- Annual report 2016 PDF English8.4Mb
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At OPI in the US we collect, test and supply human blood plasma for the manufacture of Octapharma’s lifesaving medicines. All OPI plasma collection centres are licensed by the relevant national health authority, and are operated in compliance with EU and/or US Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) and the quality and safety standards of the Plasma Protein Therapeutics Association (PPTA).
My team is responsible for regulatory affairs and quality assurance for OPI. In partnership with the operations teams in our plasma collection centres, we ensure that our business and products are compliant with the regulations and that we are operating in the most efficient and compliant way. Looking at the business in totality and working together with different functions to find solutions is the fun part of my job.
The quality systems and best practice templates in place guarantee a consistent level of information and integrity of our processes for our existing and newly opening plasma centres. We believe that quality should be a habit, not an act. And we are even more conservative when it comes to safety because we have a responsibility to our business, to our reputation and, ultimately, to our patients.
To ensure the product quality and safety, we perform tests on each and every plasma donation collected in our centres. We screen for the presence of specific blood-borne viruses, such as human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV). The plasma is physically held and electronically quarantined until successful test results are confirmed. Only then will the plasma be shipped to our European production sites to be manufactured into medicines.
OPI is in a growth phase. We have 73 plasma donation centres as of the end of 2016, and plan for 82 by the end of 2017. In August 2016 we received approval from the US FDA for our new state-of-the-art viral testing laboratory in Charlotte, North Carolina. Bringing our plasma viral testing in-house gives us more control over our processes, and will also enhance our ability to expand operations.
Patients are always in our mind and I believe that quality is everyone’s responsibility, regardless of whether or not the word is in your job title. I experienced a big eye opener when I met someone in my personal life who told me she was a recipient of plasma therapy. I had advertised for a babysitter and one of the candidates told me that she has a chronic illness and has immunoglobulin infusions on a weekly basis. Meeting a person who relies on plasma products touched me very deeply. It brought home the importance of what we are doing every day, supplying safe plasma which is manufactured into lifesaving medicines for our patients all around the world.