Patient safety based on product quality: Quality management as key factor

Monitoring side effects: Quality assurance systems at Fresenius Kabi

An important goal of quality management at Fresenius Kabi is to monitor the applicability, efficacy, and safety of products and services, as well as the success of therapies, and their continuous improvement.

This includes the monitoring of adverse reactions or events (side effects) associated with the use of medicinal products. It takes place in the context of pharmacovigilance (drug safety). The statutory pharmacovigilance commitments relate to our medicinal products for human use. Equivalent regulations exist for medical devices. In order to fulfil these obligations at Fresenius Kabi, our integrated Quality Management System (QMS), is complemented by a monitoring and reporting system, which we have established alongside product risk management that is integrated in the overarching QMS.

At a glance: The four aspects of our monitoring and reporting system

Recording side effects

An early warning system is used to gather information from various sources that is relevant to pharmaceuticals and quality. This enables us to identify product-related risks at an early stage and take corrective or preventive actions.

Evaluating side effects

We always need to be certain that the use of a drug outweighs the risk of adverse side effects. Company-wide standard operating procedures (SOPs) help us to assess the benefit-risk profiles of our products and to monitor them.

Notifying the authorities

We continuously and regularly evaluate safety-relevant information from various sources, e.g. adverse event reports from doctors or patients, and specialist medical literature, and submit the results to the regulatory authorities.

Communicating with customers and the public

We promptly inform our customers and the public about any changes we identify in product or patient safety. We either reach out directly, or as necessary by means of appropriate publication.

Everything under one roof: Our integrated quality management system

Our QMS is organized in accordance with the ISO 9001 standard, and it is binding for all organizations of Fresenius Kabi. Compliance with the standard at global level is reviewed by TÜV SÜD in annual audits. This covers an audit of 123 Fresenius Kabi organizations through a matrix certification for which several organizations with the same alignment are audited together. One further organization holds a local ISO 9001 certification. In addition, our manufacturing plants have supplementary certifications, such as ISO 13485 for medical devices, ISO 22000 for food safety, and Good Manufacturing Practice (GMP) for pharmaceuticals.

Integrated Quality Management

How we ensure the effectiveness of our quality management system: The audit and inspection score

We carry out annual internal QMS audits and we are also subject to external audits.

The external audits included 22 GMP inspections carried out by the United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Canadian drug regulatory authority Health Canada, and the European pharmaceutical authorities. TÜV SÜD as the certifying body for the ISO 9001 standard carried out 15 audits for the QMS. An audit and inspection key figure is determined annually from the GMP inspections of these authorities and the TÜV audits.

This key figure shows how many so-called major deviations were discovered on average during inspections and audits. To calculate it, we take the sum of the number of serious (major) deviations identified by the authorities and TÜV Süd and divide it by the total number of audits and inspections carried out.

Always in focus: The benefit-risk ratio of our products

We continually monitor and analyze the benefit-risk ratio of the products, and we have established various standard operating procedures for the process. For purposes of the analysis, we assess safety-relevant information from different sources, e.g. adverse event reports from doctors, patients, and specialist medical literature. We submit the results of these analyses to the relevant responsible regional or national regulatory authorities, e.g. as periodic safety reports. We monitor this statutory mandatory activity using performance indicators.

Fresenius Kabi aims to submit all periodic safety reports worldwide to authorities in due time – and hence to achieve a 100% compliance rate. In 2023, the figure for all performance indicators was above 99%.

The benefit-risk ratio of all pharmaceutical products remained unchanged in 2023.

Responding quickly and appropriately to adverse events: Our early-warning system in product risk management 

Fresenius Kabi uses the early warning system to collect information relevant to drug safety and quality from various topic areas and then evaluate it in order to identify risks at an early stage and take corrective or preventive actions. We use databases in which complaints and side effects are logged, together with internal and external audits, and key performance indicators applied for internal control and optimization of pharmacovigilance processes. This enables us to continuously evaluate the benefit-risk ratio of products worldwide.

When quality-relevant events occur, it is extremely important to act quickly and initiate and coordinate the necessary measures such as product recalls. Fresenius Kabi has named global safety officers, who take action immediately if an announcement is made.

Internal procedure instructions also ensure that we promptly forward reports on new, previously unknown side effects caused by our products to the healthcare professionals. The information is communicated e.g. in a Dear Health Care Professional Letter.

Facilitating safe handling: Labeling and product information

Complete fact-based information and labeling in accordance with statutory regulations are absolutely essential to ensure correct applications of drugs and medical devices. Fresenius Kabi’s products are classified on the basis of global or national regulations and standards, e.g. as pharmaceuticals, nutritional products, active pharmaceutical ingredients, or medical devices. The information and labeling obligations we have to comply with depend on the category of product. The marketing of these products is also subject to various legal standards and regulations. We draw up our information using global standard operating procedures in order to comply fully with our information obligations and to ensure that the product information for correct use is clear, accurate, and not misleading.

In the team for highest quality standards: Our Quality Culture Initiatives

In 2020, Fresenius Kabi launched a Quality Culture Initiative on continuous improvement of quality awareness specially for our local units. After a pilot phase with selected production sites, the initiative was rolled out at all production facilities worldwide with the slogan Quality starts with me. The initiative is directed by the Head of Global Quality Management. Every quarter, the director receives the relevant product segment status report from the quality assurance managers with information about the local initiatives at the level of the production site.

As part of the Quality Culture Initiative, the local organizations carry out surveys on the status of quality awareness regularly. They use the results to plan local campaigns on providing further support for quality awareness of all employees.