PV001: SOP FOR PHARMACOVIGILANCE (PV) SYSTEM MANAGEMENT & QPPV RESPONSIBILITIES
OBJECTIVE: To define the system for managing Pharmacovigilance (PV) activities and to describe the responsibilities of the Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with WHO, EU-GVP, and local regulatory requirements. SCOPE: This SOP applies to all PV activities in the organization, including safety data collection, evaluation, reporting, maintenance of PV system documents, and […]
PV001: SOP FOR PHARMACOVIGILANCE (PV) SYSTEM MANAGEMENT & QPPV RESPONSIBILITIES
OBJECTIVE: To define the system for managing Pharmacovigilance (PV) activities and to describe the responsibilities of the Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with WHO, EU-GMP, and local regulatory requirements. SCOPE: This SOP applies to all PV activities in the organization, including safety data collection, evaluation, reporting, maintenance of PV system documents, and […]