What is the Pharmacovigilance Audit process? In healthcare, ensuring patient safety through the integrity examination and evaluation of pharmacovigilance systems, are priorities. This is where Pharmacovigilance (PV) Audits come into the spotlight. In an industry shaped by stringent regulations and the ever-evolving complexities of pharmaceutical companies, audits assist in identifying gaps, misalignments and deviations, analyze the contributing factors and define the best course of action to mitigate any issue. They serve as a foundation for ensuring compliance, building at the same time an environment of continuous improvement and growth.
Artemis Thanasopoulou, a Pharmacovigilance Professional at Biomapas, explains, “Auditing should be an open and transparent process that helps identify and correct issues, not a punitive measure.” Her insights emphasize that auditing is not merely about meeting requirements but about embracing a culture of proactive vigilance.
What is Pharmacovigilance Auditing?
Definition and purpose
The implementation of the 2012 PV regulation established a legal obligation for the competent authorities of member states, the EMA, and the MAHs to conduct PV audits. Pharmacovigilance auditing is an independent process that evaluates the compliance of a PV system with the legal, contractual, and procedural requirements.
At its core, it aims to gather and assess evidence to determine if the necessary criteria are met through a systematic, disciplined, and documented process. In the context of pharmacovigilance (PV), these criteria should align with the requirements of the PV system and its related quality system.
Simply put, the immediate goal of PV audits is to ensure that organizations meet their obligations to regulators, and partners, by evaluating compliance, assessing the effectiveness and identifying possible risks or weaknesses in pharmacovigilance processes and systems. Ultimately, the goal is to enhance patient safety and improve public health outcomes.
What are the Types of Pharmacovigilance Audits with regard to scope?
- Internal audits: Conducted by an organization to evaluate its internal processes and systems at both global and local levels.
- External audits: Performed by independent auditors who are not part of the organization being audited, to ensure compliance with external standards of various partners (e.g. third-party service providers, distributors, out-license partners, etc.).
What are the Types of Pharmacovigilance Audits with regards to the triggers?
- Routine Audits: Scheduled regular audits to ensure ongoing compliance and effectiveness of the pharmacovigilance system.
- Triggered Audits: Conducted in response to specific events or concerns, such as significant changes in regulations, internal findings, or external complaints
- Mock Audits: Serving as preparatory internal exercises to identify potential issues and areas for improvement without the pressure of a formal audit or inspection.
- Follow-Up Audits: Performed after an initial audit to verify that corrective actions have been implemented and are effective
“These audits form an overarching framework,” Artemis notes, “separate from daily operations but essential in ensuring all conditions are met.”
What is the Pharmacovigilance Audit process?
Key Steps
Audits typically involve planning and preparation, execution, and reporting:
1. Planning and Preparation: The initial steps toward a pharmacovigilance (PV) audit involve meetings to clarify and define the audit’s objectives, scope, and the roles and responsibilities of all involved parties.
2. Execution: It is common that a “kick-off” meeting is held before the interviews with personnel to introduce everyone and set the stage. Once the agenda is established, the audit can proceed with interviews, document reviews, and demonstrations of activities, as well as an examination of archiving and storage methods.
3. Feedback Session and Reporting: Finally, the audit concludes with a presentation of the findings and a summary of the results, marking the end of the interview process. The audit report will detail the scope of the audit, include the auditor’s observations, and categorize findings as Minor, Major, or Critical, along with recommendations for improvement.
4. Root-cause analysis and Corrective and Preventive Actions (CAPA) evaluation: Post-audit the root cause analysis and the proposed CAPA will have to be evaluated. They must address the findings in a timely, targeted and adequate way.
5. Follow-up: In some cases, depending on the nature and severity of the findings, follow-up audits must be performed to ensure that the proposed corrective actions have been implemented effectively.
Tools and Methodologies
The tools and methodologies to be used should be carefully selected to ensure a comprehensive evaluation of processes and systems. Structured questionnaires form the backbone of many audits, providing a consistent framework to evaluate compliance with internal and regulatory standards. However, as Artemis Thanasopoulou explains, the interview process often goes beyond simply asking and answering questions.
“Auditing is not just about the documents; it’s also about understanding how people respond under scrutiny,” Artemis notes. “Sometimes, it’s the tone of an answer or the way someone hesitates that signals where deeper issues might lie.”
Behavioral observation methods are not typically a primary focus in pharmacovigilance audits. However, interpersonal skills and behaviors can play a role during the audit process, particularly in interviews and interactions with staff. By carefully noting body language, tone, and patterns of speech, auditors can identify areas where further investigation may be warranted. Effective communication and observation of how procedures are carried out can provide valuable insights into the organization’s pharmacovigilance practices.
When it comes to technology, advances in digitalization Electronic Data Capture (EDC) systems, audit management software and cloud-based solutions have streamlined the administrative aspects of auditing. Moreover, remote audits that a few years ago were not provided as a realistic option, are now becoming more frequent with the use of collaboration platforms that can host on-line meetings. However, when asked about the role of AI in auditing procedures, Artemis points out, “AI integration in auditing remains limited because we are still primarily evaluating human-driven processes.”
Common Areas of Focus
- Compliance with global regulatory and contractual requirements
- Effectiveness of the quality systems standard operating procedures (SOPs), training programs, and documentation practices
- Data Management for managing pharmacovigilance data
- Vendor oversight
- Performance of key processes including but not limited to PSMF management, ICSR management, Signal Detection and Risk management, Aggregate reporting etc.
Benefits of regular Pharmacovigilance Auditing
1. Early Identification of issues
Audits play a crucial role in identifying potential gaps before they become significant issues. By detecting and addressing problems early, the risk to patients is significantly reduced, ensuring their safety and well-being. “Auditing is a tool for improvement, not punishment,” she explains, highlighting that the process is about fostering transparency and trust rather than inducing fear.
2. Process and System Improvement
The insights gained from audits enable companies to refine their operations and strengthen their pharmacovigilance systems.
As Artemis points out, evolving systems can unintentionally introduce small but impactful gaps. “New contracts or minor system changes often create issues that are overlooked,” she notes. Addressing these gaps ensures processes remain robust and aligned with regulatory requirements, even as organizations grow and adapt.
3. Inspection readiness
Audits build team confidence by preparing them for regulatory inspections and high-stakes situations.
4. Strengthened Reputation
Regular audits reinforce trust with regulators and partners showcasing a company’s commitment to excellence. As Artemis highlights, an audit plan which is designed with a risk-based approach and is well-executed, not only ensures adherence to regulations, but also shows dedication to upholding the highest industry standards and secures patient safety.
What is the purpose of a mock audit?
Mock audits have gained popularity as an effective preparatory tool. These are simulated audits designed to mimic the conditions of formal audits. They are a proactive measure to enhance the robustness and compliance of a part or whole pharmacovigilance system. Many organizations perceive them as risk-free opportunity to identify and address deficiencies and gaps and to build confidence among the team, ensuring they are well-prepared and less likely to be caught off guard during an actual audit or inspection.
How They Differ from Formal Audits
The fundamental difference between mock audits and formal audits lies in their objectives and outcomes. Formal audits are official compliance evaluations, with findings potentially leading to consequences. In contrast, mock audits are preparatory exercises providing a safe environment for learning and improvement.
As Artemis Thanasopoulou explains, “Mock audits are invaluable before launching a product or entering a new market. They allow companies to identify and correct gaps before an actual audit or regulatory inspection takes place.”
Preparing Teams for High-Stakes Inspections
One of the most significant benefits of mock audits is their role in preparing teams for formal inspections by regulatory bodies. These audits simulate real-life scenarios, helping teams practice responding to tough questions, presenting documentation, and demonstrating their understanding of regulatory requirements.
Conclusion
Pharmacovigilance auditing is more than a regulatory requirement—it is a vital process for maintaining compliance and ensuring drug safety in an increasingly complex global landscape. Through regular audits and proactive mock audits, companies can build resilient pharmacovigilance systems and foster trust with stakeholders.
As Artemis aptly summarizes, “Audits are a means of identifying and correcting issues, ensuring that patients receive the safest and most effective treatments possible.” By embracing this mindset, organizations can turn audits into opportunities for continuous improvement and innovation.
