In pharmaceutical manufacturing, strict rules guarantee the efficacy, safety and compliance of the products manufactured. The guidelines of Good Manufacturing Practice (GMP) are set out in international and national laws and are binding for all pharmaceutical manufacturers.
The quality management system of ExtractumPharma Zrt. covers the entire life cycle of pharmaceutical products in line with applicable regulations.
The quality characteristics and technological details of the finished medicinal product are specified exactly and regulated in written procedures at the development/scaling-up stage.
During the commercial manufacturing phase, continuous monitoring covers, among other things, the qualification of suppliers, the formal receipt and storage of raw materials, manufacturing and quality control operations and the transport route of finished medicinal products. The commercial release of each finished product leaving the pharmaceutical factory is carried out by a duly qualified Authorised Person approved by the National Institute of Pharmacy and Nutrition (OGYÉI). The optimisation of technological and testing methods and risk analysis procedures ensure the continued compliance of the medicinal product with regulations and patient expectations throughout the product life cycle.
The most important pillars of ExtractumPharma’s quality system are continuous improvement, knowledge management and regular training to ensure the commitment of our employees to high standards of pharmaceutical compliance.