Term in GLP

Test Site

• encompasses the people, premises, and operational units necessary for conducting non-clinical health and environmental safety studies. In multi-site studies, the test facility includes the site where the Study Director is located, as well as all individual test sites that contribute to the overall investigation.

• the authority and formal responsibility for organizing and overseeing the operations of the test facility according to the Principles of Good Laboratory Practice. The test site management is responsible for ensuring that the delegated phases of the study at their respective locations adhere to these principles.

• the specific location(s) where one or more phases of a study are carried out. These individual test sites, when considered collectively or independently, can be recognized as distinct test facilities within the broader research framework.

Study Director

• the individual responsible for the overall conduct and management of the non-clinical health and environmental safety study, ensuring compliance with Good Laboratory Practice principles.

• responsible for delegated phases of the study, while the Study Director maintains oversight of the entire investigation.

• is the entity that commissions, supports, and/or submits the non-clinical health and environmental safety study for regulatory review and approval.

Master Schedule

• documented procedures that describe how to perform specific tests or activities, ensuring consistent and reliable execution of study protocols. They provide detailed guidance beyond what is typically specified in study plans or test guidelines.

• a comprehensive compilation of information that assists in assessing workloads and tracking the progress of studies within the test facility. It serves as a crucial tool for managing and coordinating the various ongoing investigations.

• an independent system designed to assure test facility management of compliance with the Principles of Good Laboratory Practice. This program helps maintain the integrity and reliability of the research conducted at the test facility.

Batch

• the article or subject that is the focus of the research study. It is the primary focus of the investigation, and its characteristics and behavior are the central points of analysis.

• any article used to provide a basis for comparison with the test item. It serves as a benchmark, allowing researchers to evaluate the differences and similarities between the test item and the reference.

• a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture. Batches are designated to ensure uniformity and consistency, allowing for accurate comparisons and reliable data collection.

Study Plan

• the article or subject that is the focus of the research study. It is the primary focus of the investigation, and its characteristics and behavior are the central points of analysis.

• comprehensive document that defines the objectives, experimental design, and procedures for conducting a non-clinical health and environmental safety study. It serves as the guiding blueprint for the entire investigation.