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In 1992, the new, 4224-m2 plant
located in Tres Cantos (Madrid) came into operation. In addition to housing the research
laboratory and library, the plant in Tres Cantos has assigned 3025 m2 to
production, 605 m2 m2
to storage facilities, 208 m2
to quality control, and 150 m2 m2
to animal housing facilities—all constructed and equipped in compliance with
Good Manufacturing Practice (GMP).
The
manufacturing processes and procedures at LETI adhere to GMP and are presently covered
by ISO
9001 certification.
In
the manufacture and standardisation of allergenic extracts, LETI adheres to the recommendations
of the Nordic Council of Medicines, and meets the requirements of both Spanish
(RD 288/91 BOE 12/3/91) and
European
Union legislation (Directive 89/342/CEE) for
immunological products for human use.
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