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Product Safety and Quality
Pharmaceutical drugs 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 adheres to legal requirements and guidelines in the course of its development activities as well as national regulations in the case of local in-house developments and in the planning and execution of clinical trials also follows so-called Good Clinical Practice (GCP). GCP is an international ethical and scientific standard for the planning, execution, documenting and reporting of clinical trials on human subjects. Compliance with this standard ensures the rights, safety and health of individuals in clinical trials in accordance with the Declaration of Helsinki, as well as the credibility of the data gathered from the clinical trial. 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
In addition to Good Clinical Practice, STADA also follows the so-called Good Manufacturing Practice (GMP) standards for its quality assurance and control. They 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 context of GMP audits, quality assurance regularly reviews both compliance with the quality standards set by the Group for its production sites and the facilities of suppliers and contract manufacturers. In addition, inspections are conducted at regular intervals by the responsible national regulatory authorities – within the EU these take place every two to three years. Within the audits carried out in reporting year 2018, no critical findings were identified. STADA requests additional EU GMP compliance inspections for production sites outside of the EU.
Despite the comprehensive quality assurance measures in place in the pharmaceutical sector and external inspections, in mid-2018 many pharmaceutical manufacturing companies, including STADA, recalled batches of products containing valsartan from all over the world as a precautionary measure. Valsartan is a drug used to treat hypertension and light to moderate heart failure. The background for the precautionary recall was an impurity in the active ingredient valsartan contained in the drug, which arose in the production process of the active ingredient producer. According to the competent German regulatory authority, the BfArM, there is no acute risk to patients.
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 central department of Corporate Pharmacovigilance. 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 reporting year 2018 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 ist products by patients. In this context, the readability and comprehensibility of a drug’s package insert take on a special meaning. During 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 is not only increased, but abuse also avoided.