Module 5 Presentations

MHRA GCP Inspections

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Types of MHRA GCP Inspections

National Programme • Routine risk-based: systems or trial-specific. • Triggered: systems or trial-specific. • Voluntary Phase I Accreditation Scheme. • Bioequivalence and bioavailability.

Requested Inspections, MAA - related • Requested by MHRA Assessors.

Joint inspections with other agencies

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