DEVELOPMENT OF GUIDELINES ON GOOD MANUFACTURING OF BIOMEDICAL CELL PRODUCTS
Abstract and keywords
Abstract (English):
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.

Keywords:
biomedicinskie kletochnye produkty, normativnoe pravovoe regulirovanie, nadlezhaschee proizvodstvo, sistema menedzhmenta kachestva, farmakonadzor
Text
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References

1. Spislit razrabotka pravil biomed

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