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- Title
Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.
- Authors
Tulina, M. A.; Pyatigorskaya, N. V.
- Abstract
The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.
- Subjects
CURRENT good manufacturing practices; BIOMATERIALS; BIOLOGICAL specimen analysis; FLEXIBLE manufacturing systems; MEDICINE; PHARMACEUTICAL industry
- Publication
Bulletin of Experimental Biology & Medicine, 2018, Vol 164, Issue 4, p579
- ISSN
0007-4888
- Publication type
Article
- DOI
10.1007/s10517-018-4035-8