Pharmacovigilance (PV) Audits and Inspections Services

At Jeyflex, we prioritize the following objectives for improving the pharmacovigilance process:

• Evaluation of Pharmacovigilance Infrastructure: Ensuring that the marketing authorization holder has the necessary personnel, robust systems, and well-equipped facilities to fulfill their pharmacovigilance obligations.
• Identification and Resolution of Non-Compliance: Methodically identifying, documenting, and addressing non-compliance that could potentially jeopardize public health.
• Enforcement Actions Based on Inspection Results: Utilizing inspection outcomes as a foundation for initiating appropriate enforcement actions whenever necessary.

Jeyflex stands as your premier pharmacovigilance partner, offering comprehensive support in various areas, including:

• Audit Preparations: Efficiently preparing for upcoming audits to ensure readiness and compliance.
• Corrective Action Preventative Action (CAPA) Management: Implementing effective strategies to address audit findings and ensure continuous improvement.
• Internal Audit Activities: Conducting internal audits to assess and enhance pharmacovigilance operations.
• Maintaining Audit Readiness: Ensuring constant readiness for potential audits and inspections through meticulous preparation and adherence to regulatory standards.

Throughout the product life cycle, adherence to policies, plans, procedures, and regulations remains crucial to ensure compliance with evolving regulatory requirements. Jeyflex provides extensive support in various audit-related activities, including audit planning, findings, program development, and recommendations.

Our approach to PV audits involves a comprehensive process:

• Planning and Preparation of Audits: Thoroughly outline the audit scope and prepare all necessary resources for a thorough assessment.
• Conducting Audits: Carrying out audits efficiently and effectively, ensuring all critical areas are meticulously evaluated.
• Reporting: Document and report audit findings clearly and concisely for comprehensive understanding and further action.
• Corrective and Preventative Actions (CAPA): Implementing corrective and preventative actions based on audit findings to ensure continuous compliance and improvement.
• Follow-Up and Close: Ensuring thorough follow-up on audit recommendations and closing the audit loop effectively.