Experiences with GLP/GCP from the pharmaceutical industry's viewpoint

Area of Science:

• Pharmaceutical development
• Regulatory affairs
• Clinical research

Background:

• European Commission Directive 91/507/EEC, effective January 1, 1992, mandates GCP compliance for clinical trials.
• Good Clinical Practice (GCP) guidelines were approved by CPMP in July 1990, effective July 1, 1991.
• Good Laboratory Practice (GLP) originated in the USA in 1978 and is adopted in OECD principles and national laws, applying to non-clinical studies.

Purpose of the Study:

• To clarify the scope and impact of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines on pharmaceutical industry operations.
• To differentiate the application of GLP to non-clinical studies versus GCP to clinical trials involving human subjects.

Main Methods:

• Analysis of European Commission Directive 91/507/EEC and its implications.
• Review of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines.
• Examination of the practical application within a clinical pharmacology unit.

Main Results:

• GCP guidelines are mandatory for all clinical trials under Directive 91/507/EEC.
• GLP guidelines are strictly for non-clinical laboratory studies, such as toxicology, and do not apply to human subject research.
• The distinction between GCP and GLP impacts daily operations in clinical pharmacology units.

Conclusions:

• Directive 91/507/EEC enforces GCP for human trials, while GLP governs non-clinical studies.
• Understanding the distinct applications of GCP and GLP is crucial for compliance in pharmaceutical research and development.
• The pharmaceutical industry must adhere to specific guidelines based on the nature of study subjects (human vs. non-clinical).