Good Laboratory Practice (GLP) describes how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived as set forth by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA), as well as the Organization for Economic Co-operation and Development (OECD) international guidelines.

It is intended for anyone involved or planning to be involved in nonclinical laboratory studies within industry, academia, government, or other testing facilities. It provides a working knowledge of GLP that supports and reinforces technical education and training.

Course Content:

Overview

Provides a brief overview of the GLP course.

History of the Good Laboratory Practices: A Breach of Trust

Discusses the need for GLP regulations including the historical events that led to their initial development. It identifies how the foundations of GLPs are translated into practical controls, guidelines, and standard procedures encountered by technical and other laboratory/research personnel.

U.S. and Global Regulatory Agencies

Describes the scope and mission of the FDA, EPA, and OECD concerning nonclinical laboratory studies. It compares the typical types of study groups submitted to the FDA and EPA, and identifies the different methods used by these agencies to inspect a submitted study’s data, testing facility, and personnel for GLP compliance.

Definitions in GLP

Identifies definitions from the FDA, EPA, and OECD GLP regulations. It is intended to help learners master specific GLP terms and differentiate key terms having a similar focus among the regulations.

Components of Compliance

Explains how the foundations of GLP are observed and expressed in nonclinical laboratory settings, and in FDA’s GLP regulations. It identifies general elements of a quality system, intersecting points between key study documents that establish study control and direction, and how to evaluate and improve SOPs used in a testing facility.

GLP Requirements of Personnel

Identifies the regulatory requirements and responsibilities for personnel involved in all aspects of regulated studies including staff (technical and non-technical), study directors, management, QA personnel, and PIs.

The Responsible Use of Laboratory Animals (LA) – Part 1

Introduces the GLP regulations pertinent to the use of animals in research and testing, as well as their intersection with the Animal Welfare Act. It identifies the appropriate methods of interaction between technicians responsible for nonclinical studies and personnel responsible for tasks related to animal care and vivarium operations.

The Responsible Use of Laboratory Animals (LA) – Part 2

Identifies GLP requirements for study conduct and how they affect interactions between technical and animal care personnel. It describes the general process of an Animal and Plant Health Inspection Service (APHIS) inspection, and how to achieve regulatory compliance in end-of-study procedures such as collection of specimens, euthanasia, and necropsy.

Standard Operating Procedures (SOPs) and Equipment Operation

Identifies the importance that SOPs for common operations and equipment maintenance have on establishing a quality system. It discusses the GLP requirements for SOP preparation and differences in requirements for equipment found in research and testing facilities, and equipment that generates or measures data.

Understanding Raw Data and Reconstruction

Discusses the importance of raw data collection and analysis in nonclinical laboratory studies. It describes what constitutes raw data, the importance of raw data, how to collect and evaluate raw data, and how reconstruction of study data is accomplished to bridge gaps in a GLP-compliant manner.

Required Reading: Study Protocols

Describes the importance and role of the protocol in nonclinical laboratory studies. It discusses how the protocol is developed and used by the study director, technicians, QA personnel, and in regulatory enforcement, as well as the reasons for documentation and communication of protocol changes and deviations to all personnel involved in the study.

Archiving Study Data and Specimens

Presents the GLP requirements for a compliant study archive including the procedures that should be used to protect an archive from common hazards. It identifies the responsibilities of all personnel typically involved in archiving.

The Quality Assurance Unit (QAU)

Describes the purpose and functions of the QAU. It discusses appropriate interactions with QA professionals during study or husbandry inspections, and the requirement for QA independence from study conduct.

Chemicals, Test Articles, and Solutions

This module identifies GLP requirements for the receipt, distribution, storage, and disposal of chemicals. It describes the role of laboratory personnel in ensuring security and integrity of test and control articles, and other commonly used substances. It also discusses the proper handling procedures for commercial products and test articles by using information provided on safety data sheets (SDSs) and SOPs.

Reporting of Study Results and Regulatory Decisions on Study Disqualification

Discusses the requirements involved in creating a final report of study results intended for submission to the regulatory authorities. It identifies the conditions that may result in the disqualification of a study by FDA or EPA, and describes the role of a compliance statement in a final report. It also shows the ways in which data integrity and overall quality is directly related to the actions of study and supervisory personnel.