Safety and Quality of Our Products


Safety & Quality of Our Products

CSL's Commitment:

As a trusted and respected provider of healthcare solutions to many communities globally, CSL is committed to the development, manufacture and supply of high quality, safe products that improve the health and wellbeing of our patients.

We will:

  • Maintain quality systems and ensure that quality processes are understood and rigorously maintained by our employees;


  • Ensure that our third parties are a part of the same process and that other pharmaceutical companies, whose products we in-source, are actively committed to these same principles;


  • Notify regulatory agencies and other stakeholders promptly and as appropriate if we become aware of any safety or quality issues with any of our products;


  • Work with the World Health Organization (WHO) and governments to investigate and prevent any instance of counterfeiting of our products;


  • Consistently apply pharmaceutical industry best practice standards for the conduct of research and development involving animals and clinical trials with patients or individuals; and


  • Implement practical business systems that protect the rights of individuals who come into contact with CSL.


Bioethics

Research and development

Medical research and development is vital in advancing solutions to disease and global health challenges. Healthcare professionals and the broader community rely on the safety and efficacy of pharmaceutical products, and that these products are proven through clinical trials and developed in a regulated environment.

At CSL, we are committed to carrying out such research in a transparent way, with respect for people in clinical trials, and with close and appropriate monitoring of animal welfare during animal based trials.

Our approach accords with government regulations and pharmaceutical industry good practice codes for clinical trials and animal testing.

Clinical trials

CSL conducts clinical trials in accordance with the current guideline for Good Clinical Practice (GCP) of the International Conference on Harmonisation (ICH), the Declaration of Helsinki, and applicable local laws and regulations of the country in which the clinical trial is conducted.

These standards outline the community's expectation of pharmaceutical companies for conducting and managing clinical trials including informed consent and the protection of patient safety and privacy.

We have well developed project management procedures that ensure the implementation of and compliance with these standards.

We are committed to ensuring the transparency and public accessibility of information related to our global clinical research activities. We register our sponsored clinical trials on a public registry before trial initiation and disclose the results of these trials in a timely fashion.

We are also committed to ensuring that, where we are involved in the in-sourcing of pharmaceutical products developed by other pharmaceutical companies, those products have been approved by the relevant regulatory agencies that monitor these standards.

Stem cell research

While CSL does not undertake research involving embryonic stem cells, we have a responsibility to continue to monitor developments in all fields of research for potential application to biological medicines for the possible benefits for patients.

Animal welfare

At CSL, we are committed to maintaining the highest standards of welfare for all animals involved in our research. Any product trials conducted using animals are licensed and closely regulated under applicable local laws and international codes of practice. We apply these laws and codes of practice rigorously.

We have Animal Ethics Committees (each an AEC), which strive to ensure that scientific activities that are conducted using animals are consistent with the relevant regulations and codes, and wherever possible and permissible by law, follow the 3R principles:

  • Replacement of animals with other methods;

  • Reduction in the number of animals used; and

  • Refinement of techniques used to reduce the impact on animals.

We will not start any scientific procedure or program involving the use of animals unless and until the AEC has approved the:

  • Scientific procedures

  • Premises; and

  • Technical qualifications of persons involved in the research.

The AEC must determine that the trials are justified, after weighing the scientific value of the projects against the potential effects on the welfare of the animals, prior to consenting to the start of any projects using animals.

Adverse events

Patient safety is of paramount importance to us.

CSL is committed to continuously evaluating the benefits and risks of our products, by collecting meaningful data on adverse events, and reporting transparently to patients, healthcare professionals and regulatory agencies.

We have an extensive pharmacovigilance program and are committed to maintaining and improving management systems and employee training that supports this program.

Quality

Our patients rely on the processes at CSL to ensure that our products meet their expectations for quality and safety. We are committed to developing, producing and marketing quality products that benefit all stakeholders including hospitals, healthcare professionals and patients.

We achieve this by ensuring that our products, processes and services meet all relevant specifications and are in compliance with all applicable local laws at every step in the production process. This includes comprehensive validation of the manufacturing equipment, facilities, processes and computer systems which control these processes.



Q. While attending a recent social event a guest related to me the story of their child who had experienced an unusual side effect after receiving a CSL product. What should I do?

A. CSL takes product quality and safety very seriously and you have a responsibility to report all adverse reactions or product quality complaints immediately. You must report this incident as soon as possible, ensuring that in doing so appropriate steps are taken to protect the privacy of the patient. Please refer to the CSL intranet for further details on how to report adverse reactions or product quality complaints.



Similarly, the appropriate training of all employees is critical to the consistent, effective collection of plasma and production of our medicines. CSL directs significant personnel and financial resources toward the ongoing training of staff to assure all employees are properly qualified to perform their work in accordance with all policies and procedures. The training of staff is documented in and tracked through electronic training systems.

We comply with applicable regulatory agency requirements and industry standards relevant to our operations such as Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP) and other similar standards applicable to the pharmaceuticals industry.

Each CSL Group company has a quality system that underpins the development, manufacture and supply of our products.

We are audited by regulatory agencies to ensure that our systems and products meet the compliance requirements of all applicable regulations.

Supply chain

Quality in the supply chain

CSL's supply chain in its simplest form involves third parties, research and development, clinical trials, pilot scale production, manufacturing, logistics, marketing distribution and postmarketing surveillance.

We require and have put in place a clear set of high level policies that cover all areas of the supply chain to ensure that we comply with cGMP and GDP.

We also establish quality agreements that relate to product driven interfaces within the CSL Group or with outside contract manufacturers. These describe roles, responsibilities and systems that help ensure compliance with cGMP and GDP requirements.

To assure the highest level of quality in products received by our patients, CSL has established validated requirements for the storage and transport of products from the sites of manufacture to our patients. Each configuration for shipment of material has been tested to assure the product remains protected from contaminants and environmental conditions which may negatively impact the safety, quality, purity and potency of the products. All product shipments from the manufacturing sites to distributors are accompanied by temperature recording devices which confirm appropriate transport of product for further distribution.

Distributors are regularly audited to assure that their facilities and processes meet the standards required for appropriate handling of CSL products.

Supply chain management

CSL selects suppliers using fair and transparent processes, making full use of competitive markets whenever possible, which ensures fair market value is paid. As part of the selection process, CSL conducts due diligence to ensure the supplier is suited to the provision of goods or services which are within the scope of CSL's normal business activities. Formal agreements with suppliers contain provisions relating to the scope of the engagement, any CSL expectations and remuneration conditions. Financial transactions are only undertaken with approved vendors established in CSL's enterprise resource planning system. We also routinely review existing supplier relationships. Any public endorsement of a supplier requires the approval of CSL Communications

We expect our third parties to comply with the applicable laws and regulations of the countries in which they operate, with the same internationally accepted best practices that we comply with, and with all the other standards set out in this Code, including:

  • Avoiding conflicts of interest that may arise as a consequence of working with CSL;

  • Behaving ethically and responsibly in the market place and supporting principles of fair competition;

  • The appropriate use of confidential information including proprietary information and trade secrets;

  • Identification and appropriate management of all risks associated with their contracts;

  • Treating all employees with dignity and respect; and

  • Managing their direct and indirect health, safety and environmental impacts in a responsible manner.

We expect third parties to continually improve their performance by setting performance objectives, executing implementation plans and taking appropriate corrective actions for deficiencies identified by internal or external assessments, inspections and management reviews.



Q. I have been asked to secure the ongoing supply of some raw materials for a new project CSL is commencing. What principles and processes should I apply in the selection of a supplier?

A. CSL has a sourcing and procurement policy that must be followed in all cases. The underlying principle is to ensure that the chosen supplier is reputable and that the selection is based on quality, product, service and price. The supplier must comply with relevant state and national legislation as well as the Code and related policies. This includes competitive sourcing principles, vendor risk assessments and supplier performance management processes. Your Site Sourcing Manager will assist you through the process.



Counterfeit products

CSL has made a clear commitment to prevent the possible distribution or patient exposure to counterfeit therapies. This includes investment in serialisation technologies which allow product to be packaged with unique numerical identifiers to provide for simple and prompt verification by distributors and government agencies that a product is genuine.

In full compliance with applicable regulatory agency guidelines for the establishment of counterfeit management procedures, CSL has implemented global counterfeit procedures. These procedures provide clear responsibilities for the internal and external communication of reports of counterfeit product and details for actions required to minimise any impact on patient safety.

Human rights

CSL recognises that we have a responsibility to respect the rights of our patients, clinical trial participants, plasma donors, healthcare professionals, clients and employees.

Where we are working with other third parties and manufacturers of products that form part of our total supply chain, we expect their policies and practices to similarly respect these rights.

Regardless of which country we are operating in, all of our operations are governed by the United Nations Declaration of Human Rights and the OECD Guidelines for Multinational Enterprises and the rights that they set out.

Practically, these translate into the following aspects of our business:

Child labour

We recognise the right of every child to be protected from economic exploitation. We are therefore committed to the minimum age labour requirements in every country in which we operate.

Clinical trial participants

Individuals should not be the subject of clinical trials without the protection of their fundamental rights as patients or without providing their fully informed consent.

We will ensure that products that are part of our research and development programs or products that we in-source from other pharmaceutical companies are not involved in any way with breaches of these rights.

Donors

We recognise that plasma and blood donors are important stakeholders in many parts of our business. We are committed to ensuring the safety of our donors from whom we draw plasma or blood, and treating them with respect and courtesy.

Employee representation

We encourage employees to raise questions and concerns directly with their supervisor/ manager. Employees have the right to have their questions answered in a fair and timely manner.

All our employees have the right to seek representation without fear of intimidation, reprisal or harassment.

Legal entitlement and minimum wage

We will comply with workplace laws in all the environments in which we operate and our employees will receive payment which meets or exceeds the minimum wage for their work and all employment benefits that they are legally entitled to receive.

In all cases, the CSL terms and conditions of employment will meet or exceed minimum legal standards.

Modern slavery

We forbid the solicitation, facilitation, or any other use of slavery or human trafficking. Under no circumstance should any engagement with CSL deprive individuals of their freedom.



Q. A supplier who we wish to work with on the basis of the quality and price of its products is unable or unwilling to answer questions relating to its employment of child labour, acceptance of workplace representation and other workplace practices. Can we proceed to buy from them?

A. No – we require our suppliers to be compliant with these workplace practices and to provide assurances that show they are committed to them. If any supplier fails to meet this standard, we must not do business with them.