Nonclinical laboratory

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

Reporting of study results 9.1. General 9.2. Content of the final report 10. Storage and retention of records and materials Subpart J - Records and Reports Sec. 58.185 Reporting of nonclinical laboratory study results. Sec. 58.190 Storage and retrieval of records and data. Sec. 58.195 Retention of records. 

Because of the success of the CGMP laws, a new line of thought was developed that involved the subject of good laboratory practices. On December 22, 1978, the regulations entitled Non-clinical Laboratory Studies were issued in the Federal Register [21]. These regulations, which became known as Good Laboratory Practice, are involved in the evaluation of nonclinical laboratory studies. 

FDA (Food and Drug Administration). (1983). Good Laboratory Practices for Nonclinical Laboratory Studies, CFR 21 Part 58, March, 1983. 

Raw data Any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a (nonclinical laboratory) study and are necessary for the reconstruction and evaluation of the report of that study. 

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. 

Nonclinical laboratory study (FDA) An experiment in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. 

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. 

Exhibit 5.1 FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies Table of Contents... 

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. 

Part 160 - GOOD LABORATORY PRACTICES FOR NONCLINICAL LABORATORY STUDIES STANDARDS... 

Quality Assurance Unit Any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the (nonclinical laboratory) studies. 

The words "nonclinical laboratory" precede the word "study" in the FDA definitions. 

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

Maintain copies of all protocols pertaining to all (nonclinical laboratory) studies for which the unit is responsible. 

List of Required Items for a Protocol of a (Nonclinical Laboratory) Study (From... 

The FDA established a GLP review task team to identify provisions in the regulations that could be amended or deleted, and this team recommended revisions to 36 GLP provisions. Recommendations were issued as a proposed rule on October 29, 1984 [15]. The proposal made various changes to definitions to reduce the amount of paperwork required for nonclinical laboratory studies and to clarify earlier GLP provisions. Similar clarifications were made to the provisions, delineating the definition and function of the study director and quality assurance unit. 

Department of Health, Education and Welfare, Food and Drug Administration. Nonclinical laboratory studies Proposed regulations for good laboratory practice. Fed Reg 41 51205-51230, 1976. 

Food and Drug Administration, Office of Planning and Evaluation. OPE Study 42 Results of the Nonclinical Laboratory Good Laboratory Practices Pilot Compliance Program. Sept. 1977. 

A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study ... 

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. 

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