• Product safety is assured through a comprehensive Quality Management system, which is implemented throughout the STADA Group.
• As part of its manufacturing activities, STADA follows the regulations and requirements as stipulated in the Good Manufacturing Practices (GMPs). They define the framework for quality assurance, production processes, and environmental conditions applicable during manufacturing of medicinal products, active pharmaceutical ingredients and cosmetics. Furthermore, STADA holds certifications according to additional international quality management systems such as HACCP and meets ISO standards if required.
• All STADA manufacturing sites hold manufacturing licenses issued by the competent authority of the respective country, where the manufacturing site is located. These licenses are based on a thorough inspection of the competent authority and will only be granted, if compliance with applicable pharmaceutical legislation is demonstrated successfully. License renewal takes place every three years, based on a successful follow up inspection. In addition, all STADA manufacturing sites located outside of the EU and providing product to EU markets, are subject to EU inspections by competent EU authorities. This process assures they also meet EU GMP requirements.
• In addition, some STADA manufacturing sites hold ISO certificates such as ISO 9001 or ISO13485, required to manufacture medical devices. ISO certifications are performed by notified bodies.
• STADA commercial affiliates holding a wholesaler license are subject to regular inspections by the local competent authorities. This assures, all legal aspects related to marketing and distribution of pharmaceutical products in their markets are in line with legal requirements.
• In order to verify compliance with current GMP guidelines, STADA’s suppliers, contract manufacturers, and service providers are part of STADA’s supplier management system. Supplier management at STADA covers the entire supplier life cycle, starting with supplier selection and qualification, as well as covering performance monitoring and supplier retirement.
• Supplier qualification is comprised of elements such as initial information gathering through questionnaires, tests of material samples, onsite audits by STADA auditors and signing of quality agreements. GMP guidelines require that medicinal products can only be manufactured by using materials provided by approved suppliers. • In order to verify compliance with current GMP guidelines, STADA’s suppliers, contract manufacturers, and service providers are subject to audits performed by STADA’s auditors. All finally approved suppliers are included in an approved supplier list.