Good Laboratory Practices - Standard Operating Procedures

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Standard operating procedures (SOPs) are developed by EPA as guidance for inspectors done under the Good Laboratory Practices (GLPs) program as set forth in the Federal Insecticide, Rodenticide and Fungicide Act and the Toxic Substances Control Act. The SOPs only are directive in nature for EPA. Testing facilities may use the SOPs as guidance in complying with the GLPs. The SOPs below provide facilities and organizations with an appreciation of EPA's objectives and the procedures employed during a GLP inspection.

GLP-C-01 Conducting a Field Studies GLP Compliance Inspection (PDF) - (6/7/99) (21pp, 65K)

GLP-C-02 Determining Compliance of Audited Studies with GLP (PDF) - (6/9/99) (25pp, 71K)

GLP-C-04 Compliance Review of Biotechnology Facilities (PDF) - (1/4/99) (72pp, 208K)

GLP-DA-01 Auditing Field Studies (Analytical Chemistry) (PDF) - (6/7/99) (12pp, 39K)

GLP-DA-02 Auditing Ecotoxicology Studies (PDF) - (6/8/99) (4pp, 20K)

GLP-DA-03 Auditing Insecticide Efficacy Studies (PDF) - (6/7/99) (3pp, 17K)

GLP-DA-04 Auditing Residue and Environmental Fate Studies (Field Portions) (PDF) - (6/6/99) (7pp, 28K)

GLP-DA-06 Auditing Antimicrobial Efficacy Studies (PDF) - (6/16/99) (13pp, 40K)

GLP-DA-07 Auditing Nature and Magnitude of the Residue in Livestock Studies (Biology Portions) (PDF) - (6/7/99) (6pp, 22K)

GLP-DA-08 Auditing Pathology Data (PDF) - (6/7/99) (7pp, 29K)

GLP-DA-09 Auditing General Toxicology Studies (PDF) - (6/7/99) (7pp, 29K)

GLP-DA-10 Auditing Genetic Toxicology Studies (PDF) - (6/7/99) (8pp, 30K)