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CSL is committed to the development, manufacture and supply of high quality, safe products that save lives, improve the health and wellbeing of patients with serious diseases and protect public health. 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.
CSL’s Audit and Risk Management Committee of the Board has oversight of CSL’s systems of risk management, compliance and control, including oversight of CSL’s quality management system.
Further, CSL’s quality function strives to maintain the highest standards through the use of global policies, procedures and electronic systems to support management of quality processes.
Our Quality Management System covers all elements of our business including:
Our plasma donor centres and facilities are frequently audited by regulatory agencies to ensure that our systems and products meet the requirements of applicable federal regulatory requirements. In addition, we routinely carry out internal audits together with audits of our suppliers to identify, measure and control the quality and safety of our products.
Through the entire product lifecycle – from the research and development bench through to product retirement – quality resources, processes and systems are there to support the organisation.
CSL recognises that donors and their plasma donations are an integral part of helping keep our promise to patients who depend on the life-saving therapies derived from plasma. It goes without saying that if there were no, or not enough donors willing to give their time and committed to donating their plasma, the quality of life of patients who depend on plasma-derived products would be negatively impacted.
For our donors, CSL Plasma has developed efficient processes and systems that focus on donor, plasma and staff safety and quality, along with donor satisfaction. By remaining focused on the safety, health and wellbeing of the donors, all efforts are made to ensure a consistent and positive donor experience is realised during the donation process. One example of how this is achieved is by having a manageable employee-to-donor ratio that allows for the safe collection of plasma per local, national and international standards while ensuring respect of the donor’s time. CSL Plasma’s internal and external management hierarchy continuously monitor its safety and quality systems to maintain an environment of safety, professionalism and donor focus in full compliance with industry standards along with local, state, federal and international regulations.
CSL Plasma donors come from an array of different cultures, backgrounds and walks of life. Many know someone who depends on plasma products for their health and wellbeing and in some cases for life itself.
Our ability to supply life-enhancing and often life-saving therapies is only made possible by ensuring a safe, quality and positive donor experience. All our centres operate to the same standards for the management and care of plasma donors.
In the U.S. and Europe, where CSL Plasma centres operate, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) require rigorous donor suitability assessments to be undertaken before plasma is donated. The assessment serves a dual purpose, ensuring that plasma is collected from a healthy donor and that the donor’s health will not be jeopardised by the plasma donation. Outcomes of an assessment are shared with the donor. Donors who are not suitable are deferred, and the reason for the deferral and its implications are clearly explained. For first-time donors, special care is undertaken to explain the benefits and potential risks of plasma donation. First-time donors also receive, review and agree to the Plasmapheresis Informed Consent, which includes detail regarding laboratory testing, data privacy, potential discomforts and risks, the purpose of plasma donation and additional information important to plasma donation. Potential donors can also review information about eligibility criteria online at the CSL Plasma website prior to making a donation or visiting a centre.
The donor assessment process requires the collection of pertinent personal information. Across all CSL Plasma centres, systems are in place to protect donor confidentiality and privacy.
Donors are monitored by fully qualified personnel at all times during the plasma donation procedure. All efforts are made to ensure donors are comfortable and relaxed during the process. Following a plasma donation, donors remain rested and some of the fluids lost during the donated process is replaced with saline.
At any point in time, donors are welcomed and encouraged to contact CSL Plasma customer service and the centre if they have any questions or concerns about their donation and the experience. Adverse events reported by donors are monitored by CSL Plasma’s Medical Affairs group. Ongoing monitoring helps to identify any trends and support the implementation of action plans, if necessary.
CSL Plasma adheres to donation limits defined by applicable regulations. We use both medical examinations and laboratory tests to test the suitability of donors to make a donation prior to every single donation. If they fail, they are not able to donate. This process is monitored through our electronic Donor Management System and underpinned by our Quality Assurance processes. In addition, the plasma collection industry has processes in place, such as the Cross Donation Check System (CDCS), that ensure a donor does not donate more frequently than is allowed under the applicable regulations.
Plasma donors can provide feedback, including complaints, either directly to the individual centres or via CSL Plasma’s customer service hub, which supports phone, web, text, chat and social media inquiries. Additionally, donor surveys are performed to listen to and monitor donor feedback, and actions are taken to improve when trends are identified. Currently, the rate of donor complaints is very low compared to the rate of yearly donations.
Our employees are instrumental to delivering on our promise. Employees must meet mandatory qualifications for their specified roles and undergo competency-based training that is specific for their position. Experienced personnel and subject matter experts evaluate a trainee’s performance before they undertake any work independently.
CSL is passionate about the customers we serve, including plasma donors and patients. Taking a patient perspective in everything we do is critically important to us and our stakeholders. Patient stories are prominently displayed in our centres, helping to reinforce with donors and employees the impact we can make. Through our Plasma P.A.L.s. (Patients and Lifesavers) programme, many of our centres have also developed relationships with patients who periodically visit to share with CSL employees and donors their experience and to thank them for their contributions. While motivating both employees and donors, patients also learn about the plasma donation process and standards used to collect the safest, highest-quality plasma.
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.
For more on safety see CSL Behring’s Commitment to Safety and Quality.
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), Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA). CSL’s Seqirus division is one of the largest influenza vaccine companies in the world and utilises both egg and cell-based production technologies, producing a broad portfolio of inactivated influenza vaccines. 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.
The development, manufacture and controlled distribution of high-quality products is only valuable and efficacious to our patients if they actually have genuine therapies available to them via a reliable and secure supply chain.
CSL has developed and implemented a supply chain security management system that combines product and security requirements, together with loss prevention practices and anti-counterfeiting measures which establish protections throughout our supply chain. Any CSL or business partner facility engaged in the collection, manufacture, storage, handling or shipment of raw or ancillary materials, products or product data, and assets must develop and implement a risk-based, comprehensive and documented supply chain security management system.
CSL has implemented global processes to quickly respond to reports of counterfeit product and assist local law enforcement and health authorities in the investigation of counterfeit reports. These reports are managed with the highest urgency with oversight and direction provided by global policies, procedures and reporting systems that assure the right representatives from all relevant functions around the world are made aware of the situation. Resources are allocated to support confirmation of product distribution channels, batch validity and product analytical testing, as requested by authorities.
While it is virtually impossible to prevent attempts to counterfeit products, CSL has undertaken significant investment to allow for product serialisation in multiple countries. Serialisation involves the use of unique identifiers on product vials and cartons that allow for rapid verification of whether product is genuine. Where serialisation regulations and systems have been approved for implementation of serialised packaging, CSL is in full compliance with these systems.
To further protect patients, CSL has begun to package product with tamper-evident measurements, which provide visual evidence that the product has been opened, providing a high level of confidence to patients and healthcare providers that the therapies that we administer are genuine.
To assure that products are transferred through approved, legitimate supply chain routes, CSL is prohibited from conducting business with any individual, group or organisation that has been designated on any sanction or blacklist.
Where practical, CSL participates in governmental supply chain security programs, whereby businesses are qualified by a regulatory agency, to maintain strong commitments to compliance, protecting our patients, and reducing our risk profile as CSL goods move across borders. The internal control and security infrastructure in place to support these programs reduces CSL’s risk and exposure to both internal and external supply chain interruptions, and reduces the likelihood of a loss event where CSL assets could be used in the counterfeit market.
