Glossary

A

• Absolute Scope 1 and Scope 2 emissions

  Absolute Scope 1 and Scope 2 emissions refer to the actual total amount of greenhouse gas emissions released. In contrast to relative emissions, these are correlated to a unit, e. g. emissions per manufactured product.

• AI-supported analysis tools

  AI-supported analysis tools are software applications that use artificial intelligence (AI) and machine learning to analyze large amounts of data, identify patterns in the data, and support decision-making processes. These tools can process complex data from a variety of sources, including texts, images, and videos. They are being used in a growing number of healthcare settings to help make informed decisions quickly and efficiently.

• Audit & Inspection Score

  The Audit & Inspection Score at Fresenius Kabi is based on the number of critical and serious non-conformances from regulatory GMP inspections and the number of serious non-conformances from TÜV ISO 9001 audits in relation to the total number of inspections and audits performed. The score shows how many deviations were identified on average during the inspections and audits considered.

B

• Biosimilars

  Biosimilars are biological drugs that are manufactured to have similar biological properties to already approved reference products. They are developed after patent protection for the reference product has expired. Biosimilars must undergo extensive testing and demonstrate similarity to the reference product in terms of efficacy, safety, and quality in order to be approved by regulatory authorities.

C

• Compounding centers

  Compounding centers are specialized facilities that produce custom or individualized pharmaceutical products for patients who cannot be treated with standardized products. This allows us to respond to individual needs.

• Corporate segment

  The Corporate segment comprises the holding functions of Fresenius SE & Co. KGaA and Fresenius Digital Technology GmbH, which provides information technology services.

E

• Enteral nutrition

  If the gastrointestinal tract is functioning, enteral nutrition is administered in the form of liquid or tube feed. Fresenius Kabi is one of the few companies in the world to offer both enteral and parenteral forms of clinical nutrition.

• Epidemiology

  Epidemiology is a branch of medicine and public health concerned with the study of disease outbreaks, their spread, and their causes in populations. Patterns of disease and health in specific populations are analyzed to identify risk factors and develop interventions to prevent and control diseases.

G

• Generics

  Generics are medicines produced after patent protection expires that contain the same active ingredient as the original medicine. They must meet the same stringent safety and quality requirements as the original medicine, and are often cost-effective alternatives, providing wider access to vital medicines.

I

• Immunogenicity

  Potential to trigger an immune response in the body.

• ISO 9001

  The ISO 9001 quality management standard is an internationally recognized and widely-used standard for quality management systems (QMS). The standard specifies minimum requirements for a QMS. Its focus is on a process-oriented approach that accompanies, documents, and reviews all key operational procedures. Even in well-functioning organizations this usually results in finding further optimization opportunities.

M

• Mass balance approach

  The mass balance approach is a method used by companies to assess and improve the sustainability of their production processes. This approach compares the amount of materials, energy, or other resources that go into a process with the amount that comes out as product, waste, or emissions at the end of the process. This allows companies to optimize their use of resources, reduce waste, and minimize environmental impact while increasing operational efficiency.

• Multi-chamber bags

  The purpose of multi-chamber bags is to keep individual components of parenteral nutrition products separated by several chambers before use. This contributes to the stability, i.e. the shelf life, of the nutrient solutions. Shortly before use, the separation is removed, and the individual components are mixed.

N

• Neonatal care

  Neonatal care is a special branch of pediatrics and adolescent medicine, and deals with the typical illnesses of newborns, and with the treatment of premature babies.

P

• Parenteral infusion solutions/nutrition

  Parenteral nutrition is the intravenous administration of vital nutrients. This is necessary if a patient's condition does not allow adequate nutrition via the gastrointestinal tract orally or with liquid and tube feeding, or not sufficiently.

• Peer reviews

  Peer reviews are used for purposes of quality assurance and validity, and are carried out by reviewers who are expert doctors and nurses. Potential weaknesses in treatment workflows, structures, and interfaces are reviewed on the basis of selected patient records and discussed in a peer dialog between the chief physicians and nursing staff of the hospital on the one hand, and the external peer team on the other hand. Potential improvements and proposals for solutions are worked out that will improve the quality of medical treatment. The aim is to establish an internal continuous improvement process, and create an open learning and safety culture.

• Pharmacokinetics

  All the processes that a drug undergoes in an organism.

R

• Reverse osmosis systems

  Reverse osmosis systems work by means of two chambers separated by a semi-permeable membrane. The membrane is designed to only allow water molecules, i.e. water in its purest form, to pass through. One chamber contains pure water, the other unfiltered or tap water that contains impurities, e.g. salts. The unfiltered water is pressed through the membrane, which ensures that the pure water does not flow back again. This produces pharmaceutical quality water.

• Risk domains

  Cybersecurity risk domains are specific areas within a company that are vulnerable to security breaches, data loss, or other cyber risks. These domains can represent different aspects of IT infrastructure, networks, applications, end devices, or employee behavior. By identifying and analyzing risk domains, we can better understand potential threats to our cybersecurity and take targeted actions to mitigate the risks, such as providing targeted employee training or conducting regular assessments of our IT infrastructure.

S

• Scope 1, Scope 2, Scope 3

  The GHG Protocol Corporate Standard divides a company's greenhouse gas emissions into three scopes. Scope 1 emissions are direct emissions from sources owned or controlled by the company. Scope 2 emissions are indirect emissions from the generation of purchased energy. Scope 3 emissions are all indirect emissions (not in Scope 2) that arise in the reporting company's value chain, including upstream and downstream emissions.

• Spent cultures (biological waste)

  Spent cultures are biological materials required for product manufacture and labaratory analysis of pharmaceuticals. On completion of the manufacturing process, it is often necessary to apply specific disposal procedures due to the biological composition and potential environmental impact.

• STEM (students, graduates and talents)

  STEM stands for mathematics, computing, science, and technology. The term refers to a wide range of studies and careers that involve these disciplines.

T

• Therapeutic compliance

  The term therapeutic compliance refers to the degree to which patients actively participate in their treatment. It indicates how well patients adhere to the doctor's instructions regarding dosage and intake times for their medication or nutritional products.

• Track-and-trace systems

  Track-and-trace systems are software solutions that enable a product to be tracked along the entire supply chain, from production to delivery to the end consumer. They are used for several purposes, such as the increase of counterfeit protection of products or in inventory management. Various technologies such as barcodes RFID (radio frequency identification), so-called smart labels, are used. Fresenius Kabi in the us, for example, uses smart labels for some of its pharmaceuticals. They enable hospitals to manage their inventory automatically.

W

• Water risks

  Water risks are the potential hazards associated with the availability, quality, and use of water for our operations. These risks can arise from water shortage, water pollution, or regulatory restrictions. Water risk analysis enables us to identify and assess risks, and take appropriate measures to maintain our operations, and meet our social and environmental responsibilities.