How Complete Are Your Chromatographic Data? Part 1.

US Good Manufacturing Practice (GMP) regulations for quality control (QC) laboratories require that laboratory records shall include complete data derived from all tests. We will explore what is meant by "complete data" in the context of a chromatography data system and, with an analysis of the United States Food and Drug Administration (FDA) 483 citations, explore the problems when a laboratory fails to understand this phrase. We will also consider if complete data includes the electronic files generated during the course of a chromatographic analysis or just the signed paper printouts. This is the first in a two-part column and in the second part we will look at paper versus electronic records in the context of complete data, what happens when things go wrong, and what is the European approach. [ABSTRACT FROM AUTHOR]