The Basics of Pharmacovigilance Audits

Safety is of utmost concern to manufacturers and governing bodies worldwide.

However, because the process can be complicated, European Union has issued several laws and guidelines over the past several years to address issues that occur as a result of safety monitoring.

Examples of such laws include those that govern pharmacovigilance audits. Given these increased regulations, it is important for pharmaceutical executives to be familiar with the regulations that pertain to pharmacovigilance audits, understand the objectives of these audits, and develop strategic planning for these audits.

Laws Governing Pharmacovigilance Audits

Several laws govern pharmacovigilance audits. Nonspecific laws include Directive 2001/20/EC and 21 Code of Federal Regulations 312.32, which pertain to the collection of adverse event data. Laws specific to pharmacovigilance in the European Union include the following:

  • Registration (EU) 1235/2010
  • Directive 2012/84/EU
  • Commission Implementing Regulation (EU) 520/2012
  • Regulation (EU) No 1027/2012
  • Directive 2012/26/EU
  • Directive 2001/83/EC
  • Regulation (EC) No. 726/2004

The aim of these laws is to decrease the number of adverse drug reactions in the European Union by enabling the collection of more accurate data on adverse events, allow personnel to assess safety issues more accurately, enable appropriate regulatory actions to increase the safety of pharmaceuticals, encourage patients to participate more actively in the process, and to allow manufacturers to be more transparent and provide more effective communication.

The regulations also serve to define the roles of marketing authorization holder and applicants, decrease duplication of services, free up resources through the simplification of safety reporting, and establish a clear legal framework for monitoring after authorization.

Most recently, the European Parliament issued modules on Good Pharmacovigilance Practices to define the process further. Of these, one of the most important is Module IV, which discusses pharmacovigilance audits.

What Happens During a Pharmacovigilance Audit?

During a pharmacovigilance audit, personnel review the quality management system currently used to collect, code, and process data for independent case study reports, the qualifications of the staff performing pharmacovigilance, and the roles and responsibilities of the European Qualified Person for Pharmacovigilance.

They also assess whether the database used to store information on adverse events is compliant with the current regulations.

The systems for ongoing safety surveillance and strategies for detecting and mitigating risk and the procedures for conducting pharmacovigilance are assessed. The literature on safety is also reviewed, as are disaster recovery and business continuity plans.

Personnel will also assess the processes and procedures for generating and reviewing reports and for collecting and assessing adverse events.

They also review procedures in the corporation’s call center and other departments for handling safety complaints, adverse events, and urgent safety issues. Procedures and contractual agreements with third party vendors regarding pharmacovigilance are also assessed.

Strategic Planning for a Pharmacovigilance Audit

The aim of an audit is to use objective evidence to evaluate the effectiveness of a pharmacovigilance program. To that effect, manufacturers should use a risk-based approach to develop an audit strategy.

Risk planning should include all pharmacovigilance processes and tasks, the quality system currently in place to address activities related to pharmacovigilance, and intra- and interdepartmental interactions.

Changes to staff and the structure of a company should also be taken into account. Strategic risk planning should also account for changes to the pharmacovigilance system since the previous audit, the important nature of the process being audited, any changes to the company that occurred since the previous audit, and the results of previous audits.

Strategic planning for a pharmacovigilance audit involves risk-based planning on the strategic, tactical, and operational levels. On a strategic level, developers should establish an audit strategy that is approved by upper management.

During the tactical planning stage, an audit plan is developed. Developers of this plan should address factors such as quality measures and critical processes within a pharmacovigilance system, areas of high risk, and areas that were not examined adequately during a previous audit.

Planning at the operational level results in a plan for individual audit engagements, prioritization of individual audit tasks, use of risk-based sampling and approaches, and a report of the audit findings according to the level of risk.

Conclusion and Next Steps

The regulations for pharmacovigilance audits have increased over the past several years. However, by using a risk-based approach to develop an audit strategy, companies can conform to these regulations.

This will enable them to monitor issues with medications more effectively and provide safer products to their consumers.

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Topics: Process, Regulations, FDA Auditing, FDA regulatory consultants, Compliance Consulting