Relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product, including but not limited to relative freedom from residual moisture or other volatile substances and pyogenic substances.
The conformance of a product or process within pre-established specifications or standards.
Describes the actions, planned and performed, to evaluate all systems and elements that influence the quality of the product or service.
Describes the actions, planned and performed, to provide confidence that all systems and elements that influence the quality of the product or service.
Refers to a component of a quality program that includes the activities and controls used to determine the accuracy and reliability of the establishment’s personnel, equipment, reagents, and operations in the manufacturing of hematopoietic progenitor cell products, including testing and product release.
Describes the actions planned and performed to develop a system to review and improve the quality of a product or process.
Refers to an integrated program of quality assessment, assurance, control and improvement.
Range is the interval between the upper and lower levels of analyte (inclusive) that have been demonstrated to be determined with precision, accuracy and linearity using the method as written.
Red blood cells
Specific molecule on the surface or within the cell cytoplasm that recognizes and binds with other specific molecules.
Spliced DNA formed from two or more different sources that have been cleaved by restriction enzymes and joined by ligases.
In the context of bone marrow transplant, often referring to the gradual increase of lymphohematopoietic cells after transplantation.
A member of a class of RNA viruses that utilizes the enzyme reverse transcriptase to reverse copy its genome into a DNA intermediate, which integrates into the host cell chromosome.
An enzyme isolated from retrovirus-infected cells that synthesizes a complementary (c)DNA strand from an RNA template.
Rhesus blood type
The capacity of a method to remain unaffected by small deliberate variations in method parameters.
Revolutions per minute
Refers to relative freedom from harmful effects to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time.
Standard deviation
Standardize
