Ensuring the safety and quality of our therapies

The development, manufacture and supply of high quality and safe products is critical to our ability to continue to save lives and improve the health and wellbeing of patients with serious diseases.

Safety Governance

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;
  • Alignment with global logistics to assure the safe and compliant transfer of product to our patients; and
  • Support for the critical safety and pharmacovigilance activities required to assure ongoing monitoring of product safety in the field.

Through the entire product lifecycle – from the research and development bench through to product retirement, quality staff and systems are there to support the organisation on a global basis.

More on our website

Visit our website for more information on CSL's approach to safety and quality.