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Product Safety and Quality
Pharmaceuticals are products that have a direct impact on people’s health. For this reason, STADA, as a pharmaceutical and health-care Company, is responsible for ensuring the Group-wide safety of its products and thus also the safety of patients.
Good Clinical Practice
To ensure product safety and quality, STADA complies with legal requirements and guidelines in its development activities or, in the case of local developments, with the respective national requirements. In addition, for the planning and conduct of clinical trials, the Group follows so-called Good Clinical Practice (GCP), an international ethical and scientific standard for the planning, conduct, documentation and reporting of clinical trials in humans. Compliance with this standard ensures that the rights, safety and well-being of trial subjects are in accordance with the Declaration of Helsinki. It also ensures the credibility of data collected during clinical trials. Contract research organizations for the execution of clinical trials in Germany and internationally are qualified by STADA and regularly audited in order to ensure GCP compliance during the conduct of a study. In addition, all clinical trials are monitored at trial sites so that any deviations from the GCP standard can be recognized at an early stage and corrected if necessary.
Good Manufacturing Practices
Within the scope of the manufacture of pharmaceutical products, STADA also follows the so-called Good Manufacturing Practice (GMP) standards for its quality assurance and control. These represent the guidelines for quality assurance in terms of both the processes and the environment in the production of pharmaceuticals and active ingredients as well as cosmetics. STADA is also certified in accordance with external, international quality assurance systems and, at its numerous production sites, not only focuses on GMP standards, but also on all relevant ISO standards. Group-wide quality assurance is carried out centrally through STADA Arzneimittel AG, whereby individual national companies are supported by regional quality assurance officers. In the 2020 financial year, the focus was on quality control, where the emphasis was on greater standardization of processes and the continuation of digitization projects. The Group also focused on consolidating the new organizational model, harmonizing and standardizing quality systems at the acquired Biopharma and Walmark production sites as well as on performance management programs and reporting systems.
Within the scope of GMP audits, compliance with GMP quality standards is regularly reviewed at both STADA’s production facilities and at suppliers and contract manufacturers. In light of the Covid-19 pandemic, these audits took place online in 2020. Following the same principle, various EU and non-EU regulatory authorities also carried out inspections at the Group’s manufacturing sites. No critical defects were identified during the inspections carried out at STADA production sites in financial year 2020.
Good Pharmacovigilance Practices
As part of a Group-wide global pharmaceutical safety system – the so-called STADA Global Pharmacovigilance System – the safety of all STADA pharmaceuticals worldwide is monitored and ensured through the collection and evaluation of all reported pharmaceutical risks. Here, STADA’s subsidiaries work in accordance with standard operating procedures (SOPs) issued by the Corporate Pharmacovigilance department. In accordance with Good Pharmacovigilance Practices (GVP) and as part of the Global Pharmacovigilance Quality System, adherence to legal requirements and STADA standard operating procedures is monitored globally by means of a pharmacovigilance auditing system. Pharmacovigilance audits required in accordance with GVP are conducted by auditors from the Medical Affairs/Corporate Pharmacovigilance department. Additionally, STADA’s GVP conformity is regularly inspected by authorities such as the German Federal Institute for Drugs and Medical Devices (BfArM). The inspections made in financial year 2020 were concluded without critical results.
In addition to the assurance of product safety, quality and effectiveness, STADA is also equally responsible for the safe use of its products by patients. In this context, the readability and comprehensibility of a drug’s package insert take on a special meaning. As part of a pharmaceutical approval procedure, readability tests for package inserts – so-called “readability user tests” – are conducted early on with representative test subjects. Through the optimization of the layout, explanations for technical terms and the use of simple sentence structures, it is possible to ensure that patients can easily read and understand the package insert. As a result, compliance (therapy adherence) for the patients is not only increased, but abuse is also avoided.