CSL Limited Annual Report 2022/23 53 Our greatest opportunity to contribute to society is through the development of new therapies for serious unmet medical needs and through the continued supply of life-saving vaccines and plasma and protein-based therapies. From developing new, innovative therapies for diseases to enabling greater access to life-saving vaccines, protecting the safety and wellbeing of our patients and communities around the world is at the centre of our purpose as a business. This includes a commitment to a positive experience and the trust of our donors, who make vital therapies possible, and to continuous engagement with the stakeholders we depend upon to fulfill our promise. In addition to material topics featured, our strategic sustainability focus areas include: • strengthening societal health through access to our existing products and therapies and investment in innovation; • being trusted by donors through a focus on their experience and wellbeing, and their communities; and • enhancing our industry position as a patientfocused and public health leader. US$13.2 billion over the reporting period distributed in supplier payments, employee wages and benefits, shareholder returns, government taxes and community contributions* * Limited assurance by Ernst & Young. Product safety and quality The development, manufacture and supply of high-quality and safe products is critical to CSL’s ability to continue to protect public health, save lives and improve the health and wellbeing of patients with rare and serious diseases. CSL employs an independent quality function that strives to maintain the highest standards through the use of global quality standards and systems. These are reflected in global policies and global and local procedures, as well as global electronic systems to support management of the quality processes. In 2022/23, CSL’s quality systems, plasma collection and manufacturing operations were subject to 473 regulatory agency inspections around the world. Of these, 21 good manufacturing practice (GMP) regulatory agency inspections took place at our manufacturing facilities and 452 regulatory inspections at our plasma collection centres. These 473 independent inspections resulted in no critical findings that prevented release of commercial product and no suspensions or terminations of licenses to market any products in markets in which CSL is active.* These results confirm that the quality systems established globally by CSL are effective and in line with regulatory agency expectations. In November 2022, as a precautionary measure, one CSL Behring lot of PRIVIGEN® was recalled from the Canadian market due to a higher rate of allergic/hypersensitivity type reactions.* Hypersensitivity and anaphylactic reactions are a known risk with immunoglobulin products. In June 2023, CSL Behring, in coordination with local health authorities, initiated a recall of one batch of CSL Behring product from the Czech and Saudi Arabian markets due to a media fill failure*. In June 2023, one CSL Seqirus lot of Tiger Snake Antivenomwas recalled from the Australian market due to a slightly lower out of specification result for potency*. This year, there were 11 counterfeit products reported to and confirmed by CSL Behring. CSL Behring is evaluating opportunities to increase the security of packaging solutions to prevent counterfeiting. In addition, CSL Behring is working with health authorities to raise awareness and educate customers on how to identify, handle and report suspected counterfeit products. During the fiscal year, CSL commenced the integration of CSL Vifor into the CSL Group. From a quality perspective, CSL Vifor is in the process of being integrated into the CSL Quality Management Systemwhilst upholding a full functioning and compliant system in the CSL Vifor business. Over the reporting period, CSL Vifor was subject to two GMP regulatory agency inspections with no critical findings that prevented release of commercial product, no suspensions or terminations of licenses to market any products in markets in which CSL Vifor is active.* 475 regulatory inspections resulted in no critical findings that prevented release of commercial product, no suspensions or terminations of licenses to market any products in markets in which CSL is active.* In addition, over the financial year, CSL Behring and CSL Seqirus pharmacovigilance and regulatory quality assurance (PVRQA) performed a total of 91 pharmacovigilance (PV) audits: • 23 on internal systems and processes across our sites, including affiliates; and • 68 on third parties that undertake PV responsibilities on CSL’s behalf in various countries all over the world. None of these audits resulted in an outcome which affected CSL’s ability to supply product. CSL Behring underwent several good manufacturing practice inspections which focused on patient safety and pharmacovigilance. None of these inspections resulted in an outcome which affected patient safety or resulted in critical findings. * Limited assurance by Ernst & Young. 9 Social
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