GXP

Application of the GLP Regulations: Lessons from Warning Letters II: Responsibilities of Test Facilities and Contract Testing Laboratories | 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 have been discussed (1 – 4). This document, referred to as CPGM 7348.808, covers the US Food and Drug Administration inspection of studies that are conducted under GLP rules (5). Attention will now be diverted to the actual application of these regulations as seen through the perspective of the FDA Warning Letters. 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 the reader with a sense of the areas of emphasis and thought patterns followed by FDA investigators. As such, they are useful tools for educating the worker about FDA expectations. The first in this series discussed the general structure of warning letters and the application of the GLP rules to Personnel Qualifications (6).

This paper will discuss an area of GLP that has generated a fair amount of conflicting discussions because of the desire on the part of study sponsors to avoid the cost of complete studies and on the part of contract testing laboratories that seek to accommodate client’s wishes. These wishes create a situation where it becomes highly tempting to circumvent the intent of the regulations.

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