Protocol development, good laboratory practice

Errors can be introduced through experimental design or the procedures used for measurement and sampling. Such errors can be reduced by adherence to good laboratory practices and adherence to established experimental protocols. Errors also can be introduced during simulation model development. Uncertainty in the development and use of models can be reduced through sensitivity analyses, comparison with similar models, and field validation. 

Tests to establish the identity, strength, and purity of the test and control articles need not comply strictly with GLP requirements (e.g., protocol, QAU inspection requirements), but good documentation of anal5dical test results (usually in a laboratory notebook) and retention of raw data for such tests is a good practice. As the development process proceeds and the same material is used in both nonclinical and clinical studies, CGMP principles wiU apply to the production and characterization processes. 

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