GXP

Application of the GLP Regulations: Lessons from Warning Letters III: Operations of the Quality Assurance Unit | IVT

In the previous series of papers, the Compliance Program Guidance Manual section that covers the inspection of good laboratory practice (GLP)-regulated organizations and studies has been discussed (1–5). This document, referred to as CPGM 7348.808, covers the US Food and Drug Administration’s inspection of studies that are conducted under GLP rules (6). The actual application of these regulations as seen through the perspective of FDA Warning Letters will be considered. Routinely reviewing warning letters is a practice followed by many experienced workers in the quality assurance (QA)/quality control (QC)/regulatory fields as they provide a sense of the FDA investigators areas of emphasis and thought-patterns. As such, they are useful tools for educating the worker on FDA expectations. The first paper in this series discussed the general structure of warning letters and the application of the GLP rules to personnel qualifications (7). The second discussed the responsibilities of test facilities and contract testing laboratories (8). This third paper will discuss the citations that have arisen from violations of GLP rules for the operations of the quality assurance unit (QAU), which is an area that appears to create confusion in organizations that do not understand the need for an independent unit that verifies the quality of the work performed by the organization. The GLP rules are intended to assure the quality and integrity of the safety data presented in submissions to FDA. Consequently, the quality of the data is extremely important, and it is the responsibility of the QAU to provide the test facility’s management with assurance that the studies are performed properly.

Note: The GLP regulations, sections from the Compliance Program Guidance Manual, and citations from warning letters will be presented in italics with the author’s discussion in normal type. Bold italics show emphasis that was given in the original document. Company responses to the citations are not shown, except in one case, as this discussion is primarily focused on the violations themselves.

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