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EAEU specified unified approach to manufacture medicinal products containing hazardous substances

EAEU specified unified approach to manufacture medicinal products containing hazardous substances

5/21/2020

The EEC Board has adopted Guidelines for manufacturing medicinal products containing hazardous substances.


The document establishes unified approaches to manufacturing medicinal products which contain potentially dangerous compounds as active substances. It is used in industrial manufacturing of such highly active pharmaceuticals as antineoplastic medicines of the alkylating agent group, some antibiotics, immunostimulatory drugs, radiopharmaceuticals and a number of other pharmaceuticals.


The Guidelines establish a common format for designing and managing enterprises which handle hazardous substances. This approach will enable to manufacture pharmaceuticals of a certain quality and protect consumers from possible harmful effects of products containing hazardous substances.


The document has been harmonized with similar Guidelines of the World Health Organization and is essential for manufacturers to prepare for the Union’s GMP (Good Manufacturing Practice) pharmaceutical inspections.


The Board’s decision will enable to assess the pharmaceutical production in a uniform canvas and prevent forming barriers associated with the Member States’ pharmaceutical inspectorates not recognizing assessment results.​