Good Laboratory Practice (GLP) studies are essential for generating nonclinical study data supporting drug product submissions or applications for human use.
According to the most basic definition, GLP is a set of principles that can be applied to ensure the quality and integrity of non-clinical laboratory studies. GLP provides a means to standardize the results of pre-clinical studies that come from different labs, in part by imposing increased documentation requirements based on standard procedures. Standardization is the driving force behind GLP.
Given the complexity, diversity and rapid change of technology and techniques for cell and gene therapy (CGT) products, such standardization is often difficult (but not impossible!) to achieve. With key considerations, GLP studies enable investigational new drug (IND) and clinical trial application (CTA) filings and human clinical trials.
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