PV Bulletin

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Inspection Readiness

Regulators inspect pharmacovigilance systems against GVP Module I quality standards and national equivalents. Monitor warning letters, inspection observations, and enforcement themes that signal where QPPV, PV quality, and operations teams should strengthen PSMF evidence, training records, and CAPA closure before the next audit.

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Digest roles: QPPV. Work email only · workflow Inspection Readiness