Ensuring the Safety and Quality of Our Therapies
CSL is committed to the development, manufacture and supply of high quality, safe products that save lives and improve the health and wellbeing of patients with serious diseases. Assuring the safety of our plasma donors and the quality of our starting materials, through to the manufacture, distribution and ongoing safety surveillance of our products, is of the utmost importance to CSL.
People are the core of CSL's quality system and quality culture, and CSL takes a product lifecycle approach to the establishment of quality systems. CSL employs an integrated quality function that strives to maintain the highest standards through the use of global policies, local procedures and global electronic systems to support management of quality processes.
Our product lifecycle approach includes global quality involvement or oversight of the following activities:
- support of research and development (R&D) and clinical trial activities to bring new products to market;
- quality audits of and support for selection of suppliers;
- implementation and management of quality systems at each plasma centre and manufacturing site;
- trending of quality and manufacturing performance;
- establishment of quality processes and standards, in collaboration with logistics operations, to assure the safe and compliant transfer of product to our patients; and
- support for the safety and pharmacovigilance activities required to assure ongoing monitoring of product safety in the field.
Our facilities are frequently audited by regulatory agencies to ensure that our systems and therapies meet the requirements of applicable federal regulatory requirements. In addition, we routinely carry out self - inspection audits together with audits of our suppliers to identify, measure, control and react to potential issues that may affect the quality and safety of our products.
Through the entire product lifecycle – from the research and development bench through to product retirement, quality staff, processes and systems are there to support the organisation on a global basis.