Controlled Release Analytical System

The guidelines stress, however, that internal quality control is not foolproof even when properly executed. Obviously it is subject to errors of both kinds , i.e. runs that are in control will occasionally be rejected and runs that are out of control occasionally accepted. Of more importance, IQC cannot usually identify sporadic gross errors or short-term disturbances in the analytical system that affect the results for individual test materials. Moreover, inferences based on IQC results are applicable only to test materials that fall within the scope of the analytical method validation. Despite these limitations, which professional experience and diligence can alleviate to a degree, internal quality control is the principal recourse available for ensuring that only data of appropriate quality are released from a laboratory. When properly executed it is very successful. 

Coutts Carrie, A., Wright, Norman A., Mieso, Ellen V. and Koenig, Jack L. (2003) The use of FT-IR imaging as an analytical tool for the characterization of drug delivery systems. J. Control. Release 93(3), 223-48. 

The DAAMS are used as the historical sample collection system. These DAAMS tubes are located in places where a Near-Real-Time monitor (MINICAMS) is not required. The historical samples are collected continuously but are only analyzed for quality control (QC) purposes. If there is an unusual event, or if a MINICAMS alarm occurs, the historical DAAMS sample tubes are analyzed to verify whether or not chemical vapors are bypassing engineering controls and being released into the environment. At the historical stations, duplicate DAAMS tubes are collocated. The primary tube is analyzed, but if the primary tube analysis is positive for CWM, the back-up tube is also analyzed. The GC column material for the back-up tube is different than the column material for the primary tube. This difference gives us an alternate analytical system for determining whedier or not CWM are present. 

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