Pharmacovigilance audits- checklists

The entry into force of the new legislation on pharmacovigilance in July 2012, established legal requirements for marketing authorisation holders to perform audits of their pharmacovigilance systems, including risk based audits of their quality systems. 

Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

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The audit will include, but not be limited to evaluation of:

• Marketing Authorisation Holder Oversight.
• Roles and Responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV).
• Responsabilities and Organisation of local Pharmacovigilance Department.
• Quality Management Systems – Procedures, Quality Assurance and Quality Control 
• Back-up procedure. 
• Training/job description/qualifications/experience pharmacovigilance and other staff.
• SOPs- global and local and including cross functional SOPs.
• Staff Training
• Case Processing of Individual Cases Safety Reports including reconciliation. Electronic reporting of Submission of Individual Cases Safety Reports. Reporting and follow up of Pregnancy cases and pediatric population exposure
• Aggregate Reports- PSUR, ASR. Interval/Periodic Safety Update Reporting- timely submission to the Health Authorities for local and common products.
• Signal identification and evaluation, if applicable.
• Risk Management Plans and updates, if applicable.
• Handling of urgent safety issues/ Crisis Management
• Safety Database.
• Literature Searches
• Medical Information.
• Compliance Metrics
• Labelling – CCDS, SmPC, USPI, PIL etc. Process of updating and implementation of changes.
• Contracts for external services; contents and management. Contracts with co-marketing and/or co-development partners
• Responses to inquiries from the local Regulatory Authorities.
• Archiving.

For more information, contact us: info@revipharm.es