CSL Ltd Annual Report 2019

7 We respect the trust that is placed in us by our stakeholders globally. To continue to earn that trust is a driving force throughout our business and is critical to our ongoing success. Trust drives value. We earn stakeholders’ trust by demonstrating responsible behaviour in our activities and decisions. Responsible conduct in the marketplace protects our reputation and sustains organisational growth. Around the world, patients and healthcare professionals know that they can rely on the quality, safety and efficacy of our therapies. International organisations such as the World Health Organization rely on us to help prevent and prepare for pandemics. Governments and regulators understand the ethical approach we bring to development and registration of our products and our commitment to fair pricing. Investors see that this trust and positive reputation is reflected in our strong financial performance. Product quality and safety 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 integrated quality function that strives to maintain the highest standards through the use of global quality standards. These are reflected in global and local policies and procedures, as well as global and local electronic systems to support management of the quality processes. In 2018/19, CSL’s quality systems, plasma collection and manufacturing operations were subject to 440 good manufacturing practice (GMP) regulatory agency inspections around the world. These independent and rigorous inspections resulted in no changes to our product marketing licenses and confirm that the quality systems established globally by CSL are established and in line with regulatory agency expectations. During the reporting period, CSL initiated three voluntary safety-related product recalls.* No recalls were initiated by regulators. In August 2018, CSL Behring initiated a recall of three units of KYBERNIN ® P in Switzerland due to units being distributed from a lot in quarantine during a requested emergency delivery. In February 2019, CSL Behring initiated a recall in Canada for albumin vials due to a gelatinous and opaque appearance of the product. In May 2019, CSL Behring voluntarily recalled five batches of ZEMAIRA vials, in the US market, as a precautionary measure due to a potential for inadequate aseptic technique during the filling process. To assure continued consistent high-quality materials from our partners, CSL Behring and Seqirus conducted a combined 580 quality (GMP) audits of suppliers worldwide. Over the reporting period, there were 11 reported cases of counterfeit product; one of these was confirmed as counterfeit, six were CSL products, with the remaining four cases having limited data available or remaining under investigation. 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 and increasing levels. Over the reporting period, CSL Behring pharmacovigilance quality assurance (PVQA) performed a total of 64 pharmacovigilance (PV) audits: –– 16 on internal systems and processes across our sites, including affiliates; and –– 48 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 reliably supply product. The safety of our donors, employees and the plasma we collect is of paramount importance. To ensure the continuous safety of the donors and the plasma supply, donors are carefully screened and tested for infectious diseases. Plasma and plasma products undergo rigorous safety controls and inspections throughout every step of the manufacturing process, from the collection of plasma to the final packaging of the finished product, to ensure that our plasma products are of the highest quality and safety. * Indicator externally assured by Ernst & Young. † Does not include Ruide. Indicator externally assured by Ernst & Young. 440 regulatory inspections of our manufacturing facilities † with no impact to licences or operations. 580 quality audits of our suppliers. † 64 pharmacovigilance audits of CSL and third-party operations with no outcomes diminishing reliable supply of quality product. US$8.4 billion distributed in supplier payments, employee wages and benefits, shareholder returns, government taxes and community contributions.* CSL Limited Annual Report 2019 26 A Trusted Health Partner