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nonconforming materials report

The Importance of Good Laboratory Practice (GLP) Protocol

There are a few key words that one should have at the forefront of their mind as they conduct non-clinical GLP studies. These words are quality and reproducibility. The regulations clearly state each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The general scope of this paper is to develop a clear understanding of the importance of the GLP protocol, what to include in the protocol and how to avoid potential findings of non- conformance. The details shared here are not an all-inclusive list of details that should be considered. The intent is to provoke thought and guidance for your organization as you plan and prepare your study protocols.

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