Conduct, nonclinical laboratory

In short, FDA is concerned that a facility be designed and constructed to ensure the adequacy of the facility for conducting nonclinical laboratory studies and to ensure the quality and integrity of study data. 

If a facility conducts nonclinical laboratory studies, it is a testing facility and is subject to inspection by the FDA to determine its GLP compliance status. If a facility conducts nonclinical laboratory studies as well as studies that do not meet the definition of nonclinical laboratory study, then only those portions of the facility that conduct nonclinical laboratory studies are subject to a GLP inspection by the FDA. The portions of the facility that conduct studies other than nonclinical laboratory studies are not subject to inspection by the FDA unless the FDA has inspectional authority under some other set of regulations. 

All laboratories operating within the United States that conduct nonclinical laboratory studies are subject to inspection... 

A laboratory that conducts nonclinical laboratory studies must provide space for the storage of raw data and specimens from such studies. Access to the archives must be controlled. This is best accomplished by providing a lockable area and by defining in the laboratory s SOPs who has access to archive materials and under what conditions (e.g., use only within the archives or check-out rights). 

Any laboratory that conducts nonclinical laboratory studies must provide dedicated space for the storage of raw data, documentation, protocols, specimens, and interim and final reports from completed studies. The laboratory must have an orderly system for storing such material, and that system must provide an expedient method for retrieving of archived materials (e.g., on the request of an the FDA inspector). 

Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study Sec. 58.120 Protocol. 

Sponsor 1) A person who initiates and supports, by provision of financial or other resources, a (nonclinical laboratory) study 2) a person who submits a (nonclinical laboratory) study to the EPA (FDA) in support of an application for a research or marketing permit or 3) a testing facility, if it both initiates and actually conducts the study. 

Study director The individual responsible for the overall conduct of a (nonclinical laboratory) study. 

Testing facility (both EPA and FDA) A person who actually conducts a (nonclinical laboratory) study, i.e., who actually uses the test substance (article) in a test system. 

Conduct of a nonclinical laboratory study Reporting of nonclinical laboratory study results Storage and retrieval of records and data Retention of records Purpose... 

Nonclinical laboratory studies must be conducted in accordance with the protocols. 

Maintain a copy of a master schedule sheet of all (nonclinical laboratory) studies conducted at the testing facility. 

Currently 23 Indian laboratories have been accredited by the Indian national GLP compliance monitoring authority as per the provisions of the OECD Principles of GLP to conduct nonclinical health and environmental safety studies. The Indian system of GLP inspection, accreditation, and monitoring of test facilities was started in 2004 (India GLP). 

When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part. 

If a testing facility refuses to permit an FDA inspection, none of the nonclinical laboratory studies or parts of studies conducted by that laboratory will be considered in support of an application for a research or marketing permit. The re-... 

The FDA has refrained from specif5ung exactly what scientific disciphnes, education, training, or expertise qualify individuals to participate in the conduct of a nonclinical laboratory study. These factors vary from study to study, and FDA has merely indicated that the question of employee qualifications should be carefully considered by laboratory management. Laboratory management therefore has considerable latitude to define job qualifications. Any reputable laboratory will find it to be in its own best interest to hire competent individuals and to provide adequate on-the-job training to qualify those individuals to perform their assigned duties. The FDA is not likely to make an issue of employee qualifications rniless an inspection reveals an obvious case of employee incompetence. 

Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. 

Each testing facility shall be of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study. 

The location of a facility (e.g., next to a farm in which pesticides, herbicides, and fertilizers are frequently used or next door to a chemical factory that generates noxious fumes) could have an adverse effect on the conduct of a nonclinical laboratory study unless the facility is designed to protect against outside environmental contaminants. Although the GLP revisions of 1987 eliminated location as a consideration in 58.41, it is still a strong consideration in the design and construction of nonclinical laboratories. 

SUBPART G PROTOCOL FOR AND CONDUCT OF A NONCLINICAL LABORATORY STUDY... 

A protocol is required for each nonclinical laboratory study. Usually a single protocol will cover only one experiment with a single test article in a single type of test system. It is permissible, however, to conduct several experiments using the same test article under a single comprehensive protocol. It is also permissible to study several test articles concurrently using a single common procedure under one protocol. 

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