Good Laboratory Practices Practices and Guidelines

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Good Laboratory Practices Practices and Guidelines Dr. Richa Singh 1 2 3 4 Discovery of potential NME Not covered by a regulatory standard Post approval stage Clinical studies in human GCP Non-clinical studies not performed in human GLP

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01
Good Laboratory Practices Practices and Guidelines


Dr. Richa Singh<br>
02
1 2 3 4 Discovery of potential NME

Not covered by a regulatory standard Post approval stage Clinical studies in human

GCP Non-clinical studies [not performed in human]

GLP GMP<br>
03
In the early 1970s, the FDA investigated a number of cases of poor practice in toxicology laboratories throughout the USA
Results of this investigation in about 40 laboratories
many cases of poorly managed studies
insufficient training of personnel
some cases of deliberate fraud
But most of the poor practice observed was not fraud and could be dealt with by implementing a system of quality management. History of GLP<br>