GLP Requirements and Current Practices

2 History and Scope of Good Laboratory Practice (GLP) Regulations 832 

Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials, edited by Joy A. Cavagnaro Copyright 2008 by John Wiley Sons, Inc. 

There are many misconceptions surrounding GLP principles. For example, sponsors often believe that the GLP provisions may be applied to the testing of samples from clinical studies. However, the introductions to the FDA GLPs 

The chapter aims to (1) provide an overview of US and global GLP regulations and (2) discuss pragmatic application of GLP elements to preclinical studies, particularly those where conventional 100% GLP compliance may not be feasible. 

1While one may insert such terms in a study report, and CROs may accept such descriptions, it should be noted that the FDA and other regulatory agencies expect that the definitive safety studies be conducted with test article that is comparable to the product proposed for the initial clinical studies. Any differences, compliance (GMP/nonGMP) or other (manufacturing methods, product attributes), must be justified within the relevant regulatory submissions (e.g., IND or BLA/CTD). 

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