Similarities and Differences Between Good Laboratory Practice and Good Clinical Practice

 

Milton V. Marshall, PhD, DABT, CCRP, President, Marshall & Associates

Abstract: Preclinical testing of investigational pharmaceuticals, medical devices, and biologics is necessary before human subjects can be exposed to them.  Many similarities exist between the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and the Good Clinical Practice (GCP) Guidelines (International Conference on Harmonisation E6 Good Clinical Practices), such as the requirement for a protocol, training documentation, and data retention. Differences also exist, such as the level of detail written in the requirements or whether adherence is mandatory. This article compares GLP regulations and GCP guidance, which have similar objectives: to determine the safety and efficacy of the product and document the study results for subsequent study reconstruction.

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What is the Purpose of GCP Training? A Quality Management Perspective

Graeme Downes, Senior Director, Clinical and PV QA, AstraZeneca

Anatoly Gorkun, Senior Manager, Scientific and Compliance Training, MedImmune

Abstract: The Good Clinical Practice (GCP) regulations require that each individual involved in conducting a clinical trial be qualified by education, training, and experience to perform the respective tasks. This article provides an overview of the purpose of GCP training, ways of delivering GCP training, and components of the GCP training package. An effective way to build a risk-based GCP training program is described.

Disclaimer: The views and opinions presented here are those of the authors and not of MedImmune or AstraZeneca.

Introduction

GCP is an international standard for clinical trials that ensures that the rights, safety, and well-being of clinical trial subjects are protected and that the clinical trial data are credible. Various legislative requirements exist for GCP training from a country level to global. For example, in the United Kingdom, regulation 28 of the UK SI 2004/1031 states that, “no person shall conduct a clinical trial… otherwise than in accordance with the conditions and principles of GCP.” From a global perspective, the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice §2.8. states: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” This means that each individual involved in conducting a clinical trial must receive training in GCP.

Even though legislative requirements have been in effect for several years and most if not all companies claim to have GCP training programs in place, non-compliance with GCP is frequently identified, as evidenced through monitoring, audit, and inspection findings.

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