BIOETHICAL STANDARDS: GLP AND GCP COMPLIANCE AS A GUARANTEE OF DRUG SAFETY AND EFFICACY

Authors

  • Shukurjonova Sevara Shuxratovna Pharm.D, Lecturer, Asia International University, Master’s student

DOI:

https://doi.org/10.55640/

Keywords:

Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Bioethics, Drug Safety, Clinical Trials, Data Integrity, Pharmacovigilance, Regulatory Compliance, Patient Protection, Informed Consent, ICH Guidelines, Pharmaceutical Ethics

Abstract

Background: The integrity of modern pharmaceutical development rests upon a foundation of rigorous ethical and procedural frameworks. Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) represent the dual pillars that ensure the transition of a chemical entity from a laboratory concept to a safe therapeutic intervention.

 Objective: This study aims to analyze the critical role of GLP and GCP compliance as the primary safeguard for drug safety and efficacy within the global regulatory landscape.

Methods: A comprehensive systematic review was conducted, examining the International Council for Harmonisation (ICH) guidelines and comparative case studies of regulatory approvals and clinical failures. The analysis focuses on the bioethical implications of data integrity and subject protection.

Results: The findings demonstrate that adherence to GLP standards in non-clinical safety studies provides a reproducible toxicological profile, which is essential for risk assessment. Simultaneously, GCP compliance ensures the ethical treatment of human participants through robust Informed Consent processes and Institutional Review Board (IRB) oversight. Data suggests that deviations from these standards not only jeopardize patient safety but also lead to significant legal and financial repercussions for pharmaceutical organizations.

Conclusion: Bioethical standards are not merely administrative requirements but are essential moral and scientific imperatives. Strengthening the global harmonization of GLP and GCP is vital for maintaining public trust in the healthcare system and ensuring that only high-quality, evidence-based medicines reach the market.

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References

1.International Council for Harmonisation (ICH). Guideline E6(R2): Good Clinical Practice: Integrated Addendum to ICH E6(R1). Geneva: ICH; 2016.

2.World Health Organization. Handbook: Good Laboratory Practice (GLP): Quality practices for regulated non-clinical research and development. 2nd ed. Geneva: WHO; 2009.

3.OECD. Principles on Good Laboratory Practice. Paris: OECD Publishing; 1998. (Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 1).

4.World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 64th WMA General Assembly, Fortaleza, Brazil; 2013.

5.U.S. Food and Drug Administration (FDA). Title 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies. Silver Spring: FDA; 2023.

6.European Medicines Agency (EMA). Guideline on the qualifications of investigators and the conduct of clinical trials. Amsterdam: EMA; 2021.

7.Emanuel EJ, Crouch RA, Arras JD, editors. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore: Johns Hopkins University Press; 2020.

8.Nightingale SL. The FDA’s Role in Ensuring the Safety and Efficacy of New Drugs. Journal of the American Medical Association (JAMA). 2018;319(12):1201-1202.

9.Kaitin KI. De-Risking Drug Discovery and Development: The Role of GLP and GCP. Clinical Pharmacology & Therapeutics. 2021;109(5):1160-1165.

10.Seiler JP. Good Laboratory Practice: The Rise and Fall of a Quality System. Drug Safety. 2019;42(11):1289-1301.

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Published

2026-02-17

Issue

Vol. 5 No. 02 (2026): Journal of Multidisciplinary Sciences and Innovations

Section

Articles

License

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Authors retain the copyright of their manuscripts, and all Open Access articles are disseminated under the terms of the Creative Commons Attribution License 4.0 (CC-BY), which licenses unrestricted use, distribution, and reproduction in any medium, provided that the original work is appropriately cited. The use of general descriptive names, trade names, trademarks, and so forth in this publication, even if not specifically identified, does not imply that these names are not protected by the relevant laws and regulations.

How to Cite

BIOETHICAL STANDARDS: GLP AND GCP COMPLIANCE AS A GUARANTEE OF DRUG SAFETY AND EFFICACY. (2026). Journal of Multidisciplinary Sciences and Innovations, 5(02), 1343-1349. https://doi.org/10.55640/

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