ABSTRACT
The Title 21:58 Code of Federal Regulations (CFR) describes the required practices for
nonclinical laboratory testing as it applies to analytical methods development and analysis
of biologic 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 Food and Drug Administration
(FDA). Given below are the overall principles for GLP compliance and the details of documents
required for GLP audits.