Audits and Inspections in Pharmacovigilance

Overview – Audits and Inspections in Pharmacovigilance

This post describes how pharmacovigilance audits are performed, from the audit planning to writing an audit report. It gives an overview of several aspects of audit conduct. Moreover, experiences with inspections and common audit and inspection findings are described.

Definition of Audit

A systematic and independent examination of trial related activities an documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported, according to the protocol, sponsor’s SOP, GCP and the applicable regulatory requirement(s). (ICH-GCP 1.6).

Keywords in the Definition of Audits:

Systematic-organized, methodical, planned, Independent-unbiased, no conflict of interest, objective 

Examination – assessment, evaluation, investigation.

Defined requirements – audit criteria, regulations, procedures

Audits in Pharmacovigilance

In the light of the changing legal situation for pharmacovigilance, the conduct of an audit in this area has an increased impact on assuring and/or improving the quality of the processing of pharmacovigilance data as part of the respective Pharmacovigilance system.

This is especially true as the Pharmacovigilance process becomes increasingly globalised and complex, while the necessity to meet timelines and the need for effectiveness remains as important as ever.

Types of Pharmacovigilance System Audits

  1. Global Pharmacovigilance systems/processes
  2. Company Affiliates (i.e., Country Office, Local Operating Company, Marketing Company)
  3. Marketing (Licensing) Partners

Global Pharmacovigilance System Audits

  • These Audits focus on central Pharmacovigilance processes which include:
    • Safety Case Processing
    • Expedited Reporting
    • Signal Detection / Safety Surveillance
    • Aggregate Reports (e.g., PSUR, PADER, etc.)
    • Literature SearchOffice of the QPPV responsibilities
  • Assess compliance with company procedures and global Pharmacovigilance regulations
  • Sample of products across therapeutic areas and a defined timeframe (vehicle to assess the system / process)
  • Systems approach focused on processes

Company Affiliates

  • Primary focus on local Pharmacovigilance responsibilities
  • Assess compliance with local and global company procedures and regulatory requirements (as applicable)
  • Evaluate the flow of safety information (from all applicable sources) from initial receipt to reporting to external parties
  • Involves many functional groups that impact the Pharmacovigilance system
    • Pharmacovigilance
    • Sales
    • Regulatory Affairs
    • Product Quality
    • Medical/Clinical
    • Information Technology
    • Marketing
    • Medical Information
  • Not just an audit of local affiliate but also of global processes to support local affiliates. Topics most often covered within scope:
    • Adverse event collection and processing
    • Expedited reporting to regulatory authorities
    • SUSAR distribution
    • Product Quality Complaint handling
    • Safety surveillance
    • Local quality systems (including compliance monitoring)
    • Regulatory functions (e.g., Aggregate reports submission, Labeling, Regulatory Authority query management, etc.)
    • Contracts and Agreements (Marketing Partners, CROs, etc.)
    • Medical Information
    • Promotional Material
    • Standard Operating Procedures (SOPs)
    • Training
    • Document Retention / Archive
    • Electronic systems used to support the Pharmacovigilance system
    • Business Continuity / Disaster Recovery

Marketing (Licensing) Partner Audits

  • Includes in-licensed and out-licensed product agreements
  • Focus on compliance with Marketing Partner agreement
    • Ensure Pharmacovigilance roles and responsibilities are defined and performed
    • Ensure appropriate exchange of safety information
  • Assess compliance with local and global company procedures and regulatory requirements (as applicable)
  • May be performed independently by company, as a joint audit between companies, or by an agreed upon consultant
  • While not an audit, Pharmacovigilance Quality Assurance Organizations may contribute to Licensing and Acquisition Due-Diligence assessments

This completes our discussion on Audits and Inspections in Pharmacovigilance. We hope this gives you flavour the various types of Audits and Inspections in pharmacovigilance and a flavour of this allied science.

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