ABSTRACT
Title 21, part 58 of the Code of Federal Regulations (CFR) describes the required practices for nonclinical laboratory testing as it applies to analytical methods development and analysis of biological samples. Note that this is separate from the good laboratory practices (GLPs) required for clinical trials, which are described elsewhere in the book. Compliance with these GLP guidelines is crucial to meet the audit requirement of the Food and Drug Administration (FDA). Given in the following are the overall principles for GLP compliance and the details of documents required for GLP audits.
