National Institutes of Standards and Technology; a federal agency that develops and certifies standard reference materials for use in various US industry applications
Nuclear magnetic resonance spectroscopy; an analytical method that generates a spectrum (based on the electromagnetic environment surrounding the nucleus of each
atom in a molecule) that serves as the chemical signature of each molecule and aids in structure determination.
nonconformity A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality
of a product unacceptable, indeterminate or not according to specified requirements. [FDA QSDG]
norleucine An amino acid, not produced by mammalian cells, but may be produced by many bacteria, especially under conditions of nutrient-poor
media. NorLeu may be substituted for Leu when a mammalian protein is expressed in bacterial cells, creating new product variants
that may be of safety concern.
Eukaryotic cells have more numerous and more complex organelles than do prokaryotic cells.
Amino-terminal or amine terminus; the amine terminus of a protein chain (with a free α-amino group).
nucleic acids DNA or RNA: chainlike molecules composed of nucleotides.
nucleotides Molecules composed of a nitrogen-rich base, phosphoric acid, and a sugar. The bases can be adenine (A), cytosine (C), guanine
(G), thymine (T), or uracil (U).
nucleus The largest organelle, an ovoid or sphere that contains all the cell's genetic material and a nucleolus that builds ribosomes.
oncogene A gene that, when expressed, can lead cells to become cancerous, usually by removing the normal constraints on their growth.
OOS Out-of-specifications result. A result that is outside the range of an approved specification. An OOS result must be investigated
to determine whether it is due to laboratory error, operator error, or process error; and a judgment made whether the result
itself is valid (accurate estimate of the true value of the analyte) or invalid. Usually, confirming an OOS result as valid
results in affected lot(s) of product being rejected.
Out of tolerance; refers to equipment or instrument which, when its calibration is checked, is outside of a defined range and requires adjustment
or repair. 2. Out of trend; a test result that is unexpected or outside of its historical or statistical trends but within specifications; and must
be investigated as a type of exception. The investigation is very similar to an OOS investigation, with the difference that
product disposition may not be affected by a confirmed out of trend result.
operon A group of functionally related, adjacent genes that operate as a unit to synthesize functionally related proteins (enzymes).
An operon group includes an operator region, a regulator gene, and structural genes equivalent to the number of enzymes in
optimization Determining and implementing process operation at the best possible and most affordable efficiency.
Documented verification that all aspects of a facility, utility or equipment that can affect product quality operate to Intended
throughout all anticipated ranges.
organelle A structurally discrete component that performs a certain function inside a eukaryotic cell.