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