Bioethical Standards: GLP and GCP Compliance as a Guarantee of Drug Safety and Efficacy
DOI:
https://doi.org/10.31149/ijimm.v4i2.2668Keywords:
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 EthicsAbstract
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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