The production process is any process used in the production of drugs, from the receipt of the starting materials, manufacture, packaging into the inner packaging to the marking and the process of packaging into the outer packaging, and the drug manufacturer is a legal entity that produces a particular drug and which can release on the market specific series of drugs. The manufacturer may manufacture medicinal products for which he has been granted marketing authorization by the Agency. A permit for the production of medicinal products shall be issued by a decision of the competent ministry for a specific place of production and a particular pharmaceutical form produced at that place of production for an indefinite period of time.
Conditions for making the drug
The Regulations also prescribe conditions in terms of space, equipment, and personnel for the production of drugs as well as quality control of medicines. Thus, the drug manufacturer is obliged to provide quality control of the starting materials, packaging materials, intermediate products, semi-finished products and manufactured medicinal products, or it may have a quality control laboratory with appropriate personnel, space, and equipment in which the quality control of the starting substances, packing materials, intermediate products, semi-finished products and each manufactured series of medicinal products.
Drugs produced from blood plasma
The manufacturer of radiopharmaceuticals, biological medicines, as well as medicines produced from blood and blood plasma of human origin, is obliged, in addition to the conditions prescribed by the law governing the field of medicines, to fulfill specific specific conditions for the production of these drugs, in order to reduce the risk during the production process in accordance with the Good Manufacturing Practices Guidelines. In the production of radiopharmaceuticals, special attention must be paid to preventing cross-contamination, adequate storage of radionuclide contaminants and the removal of radioactive waste.
Blood and blood plasma of human origin used as starting materials for the production of medicinal products must be collected and processed in accordance with the regulations on the blood transfusion service, or in accordance with the regulations on the collection and treatment of blood of human origin and its ingredients. A manufacturer who produces blood and blood plasma products of human origin is required to take special measures to prevent the transmission of infectious diseases.