Pharmaceutical drugs are products that have a direct impact on peoples’ 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 the Good Clinical Practice, STADA also follows the so-called Good Manufacturing Practice (GMP) 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 management systems and, at its numerous production sites, not only focuses on GMP standards, but also on all relevant ISO standards. Group-wide quality management is carried out centrally through STADA Arzneimittel AG, whereby regional quality assurance officers support individual, national companies.
In the context of GMP audits, Quality Management regularly reviews both compliance with quality standards set by the Group for its production sites as well as 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. STADA requests additional EU GMP compliance inspections for production sites outside of the EU.
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 with 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). In this regard, key persons responsible for pharmacovigilance are present on-site for pharmacovigilance inspections worldwide.
In 2013, STADA was the first pharmaceutical company in Germany to introduce 2D bar code labeling for its products on a large scale, thus simplifying product management and increasing customer safety – in the case of a product recall, for example. With this step, STADA has already established an initial measure on the market which, according to the EU Directive on Falsified Medicinal Products, are first set to be legally implemented throughout the EU by February 9, 2019.
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. 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 misuse also avoided.