ABSTRACT

Quality control in the analysis of drugs in biological fluids can cover a wide range of activities, or may be merely concerned with the analytical procedure in the measuring laboratory. In the extreme case of the former view, Scales stated that quality control begins with the administration of the compound and does not end until the report is signed. In using quality control data, the values obtained are used to decide whether the analysis of a particular batch can be accepted or rejected. The complete quality control data, including data from rejected batches of analyses should be maintained for subsequent evaluation. Burnett and Ayers recommend that any laboratory engaged in the analysis of drugs, whether as a routine service or as part of a research project, join an external assessment scheme in addition to establishing its own internal quality control procedures. A series of quality control samples is prepared, preferably by a skilled person outside the routine applications laboratory.