How New Drugs Are Developed: Manufacturing and cGMP
Pp. 283-329 (47)
Robert E. Smith
If a drug formulation is proved to be safe and effective with animals, more
must be made to start testing in humans. Before this can happen, “an Investigational
New Drug Application (IND)” [1, 2] must be filed with the FDA [1, 2]. FDA has a set
of quality controls for drug manufacturing, called current Good Manufacturing Practice,
or cGMP. The FDA audits manufacturing organization and it can issue FDA form 483
and a warning letter. Methods used to analyze new chemical entities include UV-Vis
and fluorescence spectrophotometry, HPLC and UPLC, ion chromatography, gas
chromatography (GC), mass spectrometry (MS), GC-MS , LC-MS, IR and NMR.
UV-Vis spectrophotometry measures the absorbance of UV and/or visible light. The
wavelengths absorbed depend on the type of compound being analyzed and the amount
of absorbance “depends on the amount present in the sample” . Fluorescence
spectrophotometry measures the emission of light that occurs at a longer wavelength
than the light that is used for excitation. Ion chromatography separates and detects ions.
Gas chromatography separates molecules in the gas phase and detects them using any of
a number of detectors, including MS. Infrared (IR) spectroscopy measures the
absorbance of IR light, which provides information about the compound being
analyzed. NMR measures the absorbance of radio frequency electromagnetic radiation
when organic compounds are placed in a strong magnetic field . It can tell the analyst
how many hydrogens and carbons there are in the sample, along with the hydrogens and
carbons to which they are bound.
cGMP, UV-Vis, fluorescence, HPLC, UPLC, GC-MS, LC-MS, ion
chromatography, FTIR, NMR.
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