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 […]
QA009: SOP FOR PROCESS VALIDATION
OBJECTIVE: The objective of process validation is to establish documented evidence that a manufacturing process, when operated within defined parameters, is capable of consistently producing a product that meets its predetermined quality attributes and specifications. SCOPE: This procedure applies to: All new products prior to commercial batch release. Existing products when significant changes occur (formulation, […]
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 […]