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 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.
Our facilities are frequently audited by regulatory agencies to ensure that our systems and therapies meet the requirements of applicable local laws and codes.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 and systems are there to support the organisation on a global basis.
Safety and the manufacture of plasma therapies
Our Promise to Donors
Our ability to supply life - enhancing and often life - saving therapies is only made possible by ensuring a positive donor experience.All our centres operate to the same standards for the management and care of plasma donors.
Every medicine possesses some level of safety risk.For plasma - derived therapies, the most important safety issue is the potential for contamination with pathogens originating from the plasma used to manufacture these therapies.Although the theoretical risk of pathogen transmission can never be zero, we use multiple and overlapping safety measures to reduce this risk to as low as is technically feasible. Since the introduction of dedicated virus reduction and removal steps and thorough quality assurance measures in plasma fractionation, there have been no reports of proven transmission of a pathogen via a plasma - derived therapy manufactured by CSL.
Safety and the manufacture of vaccines
Each year, the World Health Organization (WHO) Global Influenza Network provides CSL with influenza virus samples, which represent the influenza strains predominating in the southern and northern hemispheres.The WHO and local regional authorities then make recommendations for the composition of the vaccine for the southern and northern hemispheres respectively.This ensures that the influenza strains in the vaccine match as closely as possible with the viruses that are likely to circulate in the following southern and northern hemisphere winters.
Our production plants are maintained at the highest standard and are subject to regular inspections by regulatory authorities, including the Australian Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA).CSL’s egg-based influenza vaccine is an inactivated vaccine – i.e., it does not contain live influenza virus.The production process involves the use of validated procedures to chemically inactivate the virus.The safety and effectiveness of our influenza vaccine has been documented extensively in clinical studies conducted in healthy volunteers and from post marketing surveillance in the community.
Supplier selection and management
CSL has an active program of supplier selection and management. In many cases, the selection of suppliers is primarily driven by stringent quality, regulatory or reliability constraints.
Economics are also a very important driver in supplier selection as we continually strive to improve our operational efficiency.This helps us optimise the supply of our life - saving therapies to patients and to meet our fiscal responsibilities to shareholders.While geography is not part of our selection criteria, a significant portion of our inputs come from local suppliers.This helps avoid higher costs associated with using distant suppliers and enables CSL to contribute to local economic development.
It is CSL Policy to encourage competition and fair access to our business.In most cases, major sourcing decisions follow a formal competitive bidding process.Vendor - agnostic technical specifications are produced and issued as part of a Request for Proposal.Three bidders are typically invited to submit proposals which are evaluated thoroughly against our criteria by a sourcing panel.
For key and critical suppliers, our management process includes ongoing dialogue, formal performance reviews and quality audits.Audits can take the form of either an onsite visit or a desk based quality system review.An audit report is prepared and used to communicate the outcome to the supplier.Where deficiencies are detected, the supplier is asked to undertake corrective actions and the completion of these is followed up by CSL during subsequent inspections.Any deficiencies are risk rated and may lead to a supplier being suspended from supplying to CSL.
New suppliers are also required to demonstrate ability to comply with CSL’s CRBP and / or evidence of similar codes of conduct within their businesses.The CRBP covers aspects of organisational governance, workplace, social and environmental practices.Included in the CRBP is our approach to product safety and quality; safe, fair and rewarding workplace; community involvement; and environmental management. Existing suppliers are also required to sign up to these principles when existing supply agreements are updated or renewed.
In 2015/16, CSL ’s Board of Directors approved our first
Statement on the Prevention of Human Trafficking, Slavery and Forced Labour. The Statement details steps taken across the organisation to address modern slavery.
Security of Supply of Critical Products
The security of the supply of critical products is key to CSL’s ability to supply life - saving therapies to patients.Through a complete understanding of the sourcing, origin and supply chain risks of all materials required to manufacture CSL’s products, CSL can ensure a continuity of supply.Maintaining the security of supply is a continuous process where both new and existing supplies are reviewed and actions taken to mitigate any risks to supply that are identified.
To mitigate the likelihood of critical shortages in our products, CSL has:
- A watch list of CSL’s essential drugs
- Established a robust monitoring system to prevent and predict possible shortages of CSL’s essential drugs
- Processes in place for the notification of hospitals and other relevant bodies in the event of drug supply shortages.