CSL Limited Annual Report 2021/22 50 9 Social Product safety and quality The development, manufacture and supply of high-quality and safe products is critical to our 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. These are reflected in global policies, global and local procedures, as well as global electronic systems to support management of the quality processes. In 2021/22, CSL’s quality systems, plasma collection and manufacturing operations were subject to 406 regulatory agency inspections* around the world. These independent inspections resulted in no suspensions or terminations of a licence to market a product in any market in which CSL is active and confirm that the quality systems established globally by CSL are effective and in line with regulatory agency expectations. 406 regulatory inspections of our manufacturing facilities and plasma collection centres* with no suspensions or terminations of a licence to market a product in any market in which CSL is active To assure continued consistent high-quality materials from our partners, CSL Behring and CSL Seqirus conducted a combined 678 quality regulatory audits* of suppliers worldwide, comprised of on-site, virtual, and paper-based audits. Over the reporting period, there were 12 reported cases of suspected counterfeit products from CSL customers. CSL was able to confirm that three of the 12 cases were counterfeit products, three investigations could not confirm the counterfeit status and six remain under investigation. Over the reporting period, as a precautionary measure, six lots of PRIVIGEN and four lots of HIZENTRA were voluntarily withdrawn from the US market due to a higher rate of allergic/hypersensitivity type reactions. Hypersensitivity and anaphylactic reactions are a known risk with immune globulin products. Across our operations, there were no safety-related recalls of finished product initiated by a regulator. Oversight and management of pharmacovigilance and clinical safety affords our patients the opportunity to fully realise the benefits of our products. CSL’s Global Clinical Safety and Pharmacovigilance function continues to assure the safety of patients and clinical study participants while further deepening its capabilities and improved quality outputs. Compliance metrics have remained at high levels. Over the reporting period, CSL Behring and CSL Seqirus pharmacovigilance quality assurance (PVQA) performed a total of 69 pharmacovigilance (PV) audits: • 20 on internal systems and processes across our sites, including affiliates; and • 49 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 our ability to supply product. CSL Behring underwent several GMP inspections which focused on patient safety and pharmacovigilance. None of these inspections resulted in an outcome which affected patient safety nor resulted in critical findings. Supply continuity and resilience, including human rights and responsible supply chain. To meet the global demand for CSL’s lifesaving medicines, we are focused on driving a global mindset and creating an end-to-end operation organisation that is modern and scalable, from plasma collection through to our patients. As an industry, collecting plasma during the global pandemic has been challenging. COVID-19 has presented the plasma industry with many challenges with the ability to collect plasma having been the most adversely affected. CSL Plasma has continued to implement a number of targeted initiatives focussing on growing plasma collections for example, donor fees were increased industrywide. We enhanced our operating and marketing efforts to attract not only new donors but also lapsed donors, both of which are an important source of future donations. We also provided influenza vaccination vouchers to US plasma donors following the completion of two plasma donations made within a calendar month and introduced new technologies, such as our donor app, to improve the donor experience. CSL has continued to implement strategic partnerships with contract manufacturers to establish services that increase capacity and mitigate risks. Several new partnerships entered the commercial supply phase which has enabled CSL to spread singled sourced product supply over multiple manufacturers. These partnerships will also deliver greater capacity to support CSL’s growth plans. Many projects are in various stages of the technology transfer process and when delivered will further increase supply reliability and resilience of CSL’s most important products. Over the reporting period, CSL enhanced its third-party risk management (TPRM) digital tool, by means of amended or additional questions for supplier self-assessments, which was released in 2021. The tool assesses risks across new vendors. Since the launch of TPRM we have loaded 170 vendors and only two were identified as high risk. CSL is also in the process of rolling out DisasterAware, a digital platform that provides early indication warnings to our procurement team of natural and human-induced risks based on the physical location of our vendors. This will go live in the second half of 2022. CSL also operates an on-going process of vendor audits and we conducted 678 such audits during the reporting period. We continue to refine our tools in this space and this level of effort reflects our continued focus on understanding our suppliers and our commitment to enabling a reliable supply of our therapies. 678 quality audits of suppliers* *Limited assurance by Ernst & Young.