Non-clinical laboratory study

Non-clinical laboratory studies used to investigate microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life, and other characteristics of the device. 

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. 

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 (non-clinical laboratory) studies. 

The GLP rules were first introduced in 1976 in the US by the Food and Drug Administration (FDA) for non-clinical laboratory studies after some irregularities in investigations and reports of pharmacentical companies were revealed. The aim was to create a quality standard for laboratory investigations. 

CFR 21 Part 58 — Good Laboratory Practice for Non-clinical Laboratory Studies... 

Non-clinical laboratory studies Good laboratory practice regulations, Fedl. Reg., (1978) 43, 59986. 

Reinsch, Susan, "Economic Impact Assessment of Proposed Rule-making—Non-Clinical Laboratory Studies Good Laboratory Practices", Food and Drug Administration, Rockville, Maryland, 1978 (mimeograph). 

Note Data may include computer printouts, magnetic media, and recorded data from automated instruments that are the result of the original observations, and activities of a non-clinical laboratory study necessary for the reconstruction and evaluation of the study report (electronic copies of electronic record files can be considered electronic record files provided that the data transfer processes have been verified). 

Quality assurance activities actually begin early in the drug development process—in the analytical phase. United States requirements5 are established as early as non-clinical laboratory studies. At this early phase, the audit program concentrates on in vivo and in vitro experiments, focusing on early drug entities. These drug entities are tested under laboratory conditions to determine their potential safety risk. At this phase, human subjects (e.g., clinical studies) or field trials in animals are not involved. 

United States Code of Federal Regulations Title 21, Part 58, Good Laboratory Practice for Non-Clinical Laboratory Studies. 

In the United States, GLP regulations (21 CFR 58) apply to safety or animal toxicology studies performed during research and development. These regulations define GLPs for conducting non-clinical laboratory studies that support or are intended to support applications for research or marketing permits for products... 

Maintaining a copy of the master schedule sheet of all non-clinical laboratory studies, indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of sponsor, and name of study director. 

Maintaining copies of all protocols pertaining to all non-clinical laboratory studies for which the unit is responsible. 

Inspecting each non-clinical laboratory study at adequate intervals to ensure the integrity of the study. 

Food and Drug Administration Non-Clinical Laboratory Studies, Good Laboratory Practice Regulations. U.S. Federal Register, vol. 41, No. 225, November 19, 1976. pp. 51206-51226 (Proposed Regulations) and vol. 43. No. 247, December 22. 1978, pp. 59986- 60020. (Final Rule). 

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