Abstract
Preclinical studies are performed to evaluate the safety and toxicology of a new product for testing in humans. Animal studies offer an important stepping-stone toward the clinical trial in which they are an important and integral part of developing new biomedical products to assess potential risks and safety to human patients. These nonclinical studies must comply with Good Laboratory Practice (GLP) regulations as researchers embrace the changes required to translate basic science research into clinical discoveries. The purpose of GLP guidelines is to address organizational structure, personnel responsibilities, personnel training practices, quality assurance, facilities, equipment, standard operating procedures, study documentation, recording, and sample retention. The importance of following the regulatory guidelines is vital in this research as the consequences of noncompliance can be severe. The knowledge of Food and Drug Administration (FDA) regulations is vital for every researcher; this chapter highlights the regulatory knowledge that is essential to perform successful leading-edge research. Any investigator who is interested in conducting GLP studies must perform a needs assessment and gap analysis to ensure proper selection and execution of the GLP model. The main goal of GLP is to assure that studies produce data that are reliable, repeatable, auditable, and globally accepted.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Change history
16 March 2022
In the original version of this chapter, figure 4 on page 88 was not complete. The full figure has been updated in the chapter now.
References
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). 21. C.F.R. § 58.
European Commission. (2004). Directive 2004/9/EC: On the inspection and verification of good laboratory practice (GLP). https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:050:0028:0043:EN:PDF. Last accessed on 10/01/2020.
European Commission. (2004). 2004/10/EC: On the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:050:0044:0059:EN:PDF. Last accessed on 10/01/2020.
Arnold & Porter Kaye Scholer LLP. (2016). FDA proposes important revisions to good laboratory practices regulations. https://www.lexology.com/library/detail.aspx?g=42b752f8-f746-43d1-ada4-d77fda96d406. Last accessed on 10/01/2020.
OECD (Organization for Co-operation and Development). (1981, revised 1997). Council decision on the mutual acceptance of data in the assessment of chemicals. http://www.oecd.org/chemicalsafety/testing/councildecisionsonglp.htm. Last accessed on 10/01/2020.
Parascandola, J. (1995). The public health service and the control of biologics. Public Health Reports, 110, 774–775.
Schneider K (1983) Faking it: The case against Industrial Bio-Test Laboratories. Amicus Journal. Spring:14-26.
Baldershwiler, A. M. (2003). History of FDA Food laboratory practices. Quality Assurance Journal, 7, 157–161.
European Commission. (2004). Good laboratory practice. http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice_en. Last accessed on 10/01/2020.
Bolon, B., Baze, W., Shilling, C. J., Keatley, K. L., Patrick, D. J., & Schafer, K. A. (2018). Good laboratory practice in the academic setting: Fundamental principles for nonclinical safety assessment and GLP-compliant pathology support when developing innovative biomedical products. ILAR Journal, 59, 18–28.
OECD (Organization for Co-operation and Development). (1997). OECD series on principles of good laboratory practice and compliance monitoring. https://www.oecd-ilibrary.org/environment/oecd-series-on-principles-of-good-laboratory-practice-and-compliance-monitoring_2077785x. Last accessed on 10/01/2020.
FDA (U.S. Food and Drug Administration). (2020). Nonclinical laboratories inspected under good laboratory practices. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/nonclinical-laboratories-inspected-under-good-laboratory-practices. Last accessed on 10/01/2020.
Good Laboratory Practice Regulations, Final rule. Food and Drug Administration (FDA) issued. 52 FR 33768, Codified at 21. C.F.R. § 58 (09/04/1987).
FDA published a proposal to amend the agency’s regulations in 21 CFR Part 58. U.S. Food and Drug Administration issued. 49 FR 43530, amend 21. C.F.R. § 58 (10/29/1984).
Center for Drug Evaluation and Research issued (1981, last revised 2007) Good Laboratory Practice Regulations Questions and Answers. Docket Number: HFA-305.
EMA (European Medicines Agency). (2018). Good laboratory practice compliance. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000158.jsp. Last accessed on 10/01/2020.
ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) Safety Guidelines. https://www.ich.org/page/safety-guidelines. Last accessed on 10/01/2020.
PMDA (Pharmaceuticals and Medical Devices Agency). (2012). Ministerial ordinance on Good Laboratory Practice for nonclinical safety studies of drugs. https://www.pmda.go.jp/files/000153713.pdf. Last accessed on 10/01/2020.
PMDA (Pharmaceuticals and Medical Devices Agency). (2012). Ministerial ordinance on Good Laboratory Practice for nonclinical safety studies of medical devices. https://www.pmda.go.jp/files/000153066.pdf. Last accessed on 10/01/2020.
Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research issued. (2010). M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Docket number: FDA-2008-D-0470 (2010).
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Study Director, 21. C.F.R. § 58.33.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Quality assurance unit, 21. C.F.R. § 58.35.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Personnel, 21. C.F.R. § 58.29.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Animal care facilities, 21. C.F.R. § 58.43.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Animal supply facilities, 21. C.F.R. § 58.45.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Animal care, 21. C.F.R. § 58.90.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Conduct a nonclinical laboratory study, 21. C.F.R. § 58.130.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Standard operating procedures, 21. C.F.R. § 58.81.
OECD (Organization for Co-operation and Development). (2018). Mutual acceptance of data (MAD). http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm. Last accessed on 10/01/2020.
Good Laboratory Practice for Nonclinical Laboratory Studies. (2019). Test and control article characterization, 21. C.F.R. § 58.105.
U.S. Food and Drug Administration (FDA). (2020). FDA regulations relating to good clinical practice and clinical trials. https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm#FDARegulations. Last accessed on 10/01/2020.
FDA (U.S. Food and Drug Administration). (2001). Food and drug administration compliance program guidance manual. Chapter 48: Bioresearch monitoring—Good Laboratory Practice (Nonclinical Laboratories). https://www.fda.gov/downloads/iceci/enforcementactions/bioresearchmonitoring/ucm133765.pdf. Last accessed on 10/01/2020.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2022 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Khan, A., Lee, YS., Hare, J.M. (2022). GLP Regulations for Nonclinical Studies. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_5
Download citation
DOI: https://doi.org/10.1007/978-3-030-75537-9_5
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-75535-5
Online ISBN: 978-3-030-75537-9
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)