Ensuring the Safety and Quality of Our Therapies
CSL is committed to maintaining the highest standards of safety and quality throughout all stages and aspects of the product life cycle.
When developing therapies for use in patients, we conduct our clinical trials in accordance with the current Guideline for Good Clinical Practice of the International Conference on Harmonisation. Compliance with this standard provides public assurance that the rights, safety and wellbeing of clinical trial participants are protected and that the safety and efficacy data are credible. We conduct clinical trials in a range of countries to ensure the safety and efficacy of our medicines is evaluated in diverse populations and ethnicities. We disclose our clinical trial results in a timely fashion, regardless of outcome, on a publically available results database, in addition to major medical and scientific journals.
Safety and quality continue to be our top priorities during the manufacture of our therapies and when we in-license medicines manufactured by other pharmaceutical companies. We strive to ensure that our products, processes and services meet all relevant specifications and are in compliance with applicable local laws and industry standards, including current Good Laboratory Practices (cGLP), current Good Manufacturing Practices (cGMP), current Good Distribution Practices (cGDP) and other similar standards applicable to the pharmaceutical industry.
We 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.
We provide appropriate and ongoing education and training to our employees involved in the manufacture, testing and distribution of our therapies to ensure they are equipped to perform their duties effectively and in compliance with methods and processes approved by regulatory agencies.
CSL is committed to continuous evaluation of the benefits and risks of our therapies. We maintain a global pharmacovigilance system designed to capture, investigate and report any adverse event associated with or thought to be associated with the use of our therapies. This system ensures CSL can rapidly evaluate safety reports and provide appropriate safety information to patients, healthcare providers and regulators and take prompt action if necessary.
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
CSL operates the largest influenza vaccine manufacturing plant in the southern hemisphere, located in Parkville, Australia. The plant has a manufacturing capacity of up to 80 million doses of influenza vaccine each year, produced for markets including Australia, US and Europe.
Each year, the World Health Organisation (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 dedicated production plant is maintained at the highest standard and is subject to regular inspections by regulatory authorities, including the Australian Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA). CSL’s 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.
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.