One of the early questions facing the regulatory strategists in a start up drug development company is when to worry about complying with the Good Laboratory Practice (GLP) requirements. This concern is particularly relevant when a nonclinical laboratory study involves early safety studies for a test article and there is a need to divert resources to take a given project to the next level.

In general, compliance with GLP requirements is highly encouraged if the study is being performed to support a regulatory submission for a marketing application. 21 C.F.R. Part 58 articulates the GLP regulations for nonclinical laboratory studies. The intent of GLP is to provide a framework for conducting well-controlled studies while maintaining the quality and integrity of the data being relied on in a marketing application.  When the study is being outsourced to a nonclinical laboratory, the FDA relies heavily on documented adherence to GLP requirements in judging the acceptability of the data submitted in support of marketing permits. Therefore, prior to any outsourcing of nonclinical laboratory studies, examining the standard operating procedures, and particularly the degree of adherence of a given candidate company can prove essential.

Historically, the number of GLP inspections conducted by the FDA averaged less than 5 percent among all of the FDA facilities inspected.  Even though this number may appear low, the FDA still conducts inspections regularly and further audits the data to ascertain GLP compliance. Failure to adequately comply with GLP regulations can lead to the issuance of a warning letter. The GLP violations leading to the issuance of a warning letter has averaged one or two a year in the past few years. If deficiencies are not remedied, there is a risk that FDA disqualifies the data and/or results submitted in support of the marketing application for the products that it regulates. The GLP-related issues have rarely been tested in the courts.

Be aware that not all of the GLP provisions apply to all studies, especially in those where GLP provisions may compromise proper science. Should there be a need, there are opportunities to obtain an exemption from specific provisions of the GLP for special nonclinical laboratory studies