UDC 61

DEVELOPMENT OF GUIDELINES ON GOOD MANUFACTURING OF BIOMEDICAL CELL PRODUCTS

Published в Acta biomedica scientifica · Volume 2, Issue 3, 2017 · Pages 58–62 · Rubrics: Clinical Pharmacology and Drugs
DOI 10.12737/article_59f035fb9ec0d8.64599419
Received: 17.10.2017 Accepted: 07.12.2017 Published: 07.12.2017
Authors
1 Moskva, Moscow, Russian Federation
2 I.M. Sechenov First Moscow State Medical University (Institute of Pharmacy and Translational Medicine, Deputy Director for Science)
Moskva, Moscow, Russian Federation
V stat'e predstavlen garmonizirovannyy s mezhdunarodnymi trebovaniyami proekt Pravil nadlezhaschey praktiki proizvodstva biomedicinskih kletochnyh produktov (BMKP), vklyuchayuschiy specificheskie trebovaniya k donoram, procedure zabora biomateriala i ego transportirovki na proizvodstvo, sisteme upravleniya riskami, sisteme proslezhivaemosti, processingu, obosnovanie minimal'no manipulirovannyh BMKP, trebovaniya po vhodnomu kontrolyu, vnutriproizvodstvennomu kontrolyu i kontrolyu gotovogo BMKP, farmakobezopasnosti.
biomedicinskie kletochnye produkty normativnoe pravovoe regulirovanie nadlezhaschee proizvodstvo sistema menedzhmenta kachestva farmakonadzor
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References

1. Spislit razrabotka pravil biomed

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