Pharmacovigilance Audits

The audit in general is a systematic and independent examination of activities to determine whether the evaluated activities were performed according to defined requirements.

Pharmacovigilance (PV) system is defined as a system used by an organisation to fulfil its legal tasks and responsibilities in relation to drug safety. It is designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Pharmacovigilance tasks have to be carried out both for marketed and unmarketed products.

The PV audit activities verify, by evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a PV system including its quality system for PV activities. The audit evidence can be relevant and verifiable records, statements or any other information.

In accordance with the EU Guideline on good pharmacovigilance practices, Marketing Authorisation Holders (MAHs) are required to perform regular risk-based audits of their PV system, and can any time be inspected by a governmental or official drug regulatory authority, by license partners, internal auditors or others.

The aim of these audits is to conduct a systematic, independent, disciplined and documented process to obtain evidence of a functioning PV system; to evaluate the evidence objectively and determine whether the system meets its goals; and then to contribute to improving risk management, control, and governance processes.

Dr. Haney Pharma provides PV Audits as well as advice and support to be well prepared for an external audit. Thus, all regulatory requirements are met. Dr. Haney Pharma as a Service Provider has an expert audit team with national and international audit experience and can adapt to a variety of situations to meet the expectations of its clients. While some clients prefer for contract auditors to use the SOPs of their organisation and associated tools, Dr. Haney Pharma can also provide its own document templates.

Chief Pharmacovigilance auditor Dr. M. Shoeb

Audit Process

The audit process usually starts with planning and preparation, then the audit is conducted, followed by reporting and ending with follow up and closure.

Audit Plan

Usually the audit plan consists of the following steps:

  • Pre-audit meeting to get a general vision of the organisation and scope of the process.
  • Development and agreement of an audit plan defining audit objectives, scope and roles and responsibilities.
  • Thorough review of relevant organisational documents such as SOPs, PSMF and Pharmacovigilance Agreements before the audit, with total safety and confidentiality. This will allow Dr. Haney Pharma to be aware of the organisation system which can save time during the on-site audit and make it even more efficient.
  • Development and agreement of audit agenda defining topics and personnel involved along with proposed time.

The duration of the audit will depend on the number of topics included in the scope of the audit, based on their relevance to the organisation audited. A standard pharmacovigilance audit can be conducted within 2 to 4 working days. The Pharmacovigilance audit could include the following topics:

  • Structure and Responsibilities of the pharmacovigilance organisation
  • Pharmacovigilance System Master File (PSMF) maintenance
  • Quality Management Systems
  • Pharmacovigilance processes, Standard operating procedures (SOPs), manuals, etc.
  • Literature Screening
  • Management and reporting of adverse reactions
  • Medical information
  • Signal Detection and Management
  • Risk Management System
  • Periodic Safety Reporting
  • Maintenance of approved Product Information
  • Training
  • Record management, Archiving, Validation of Computer Systems, Security, Back-up and Disaster Recovery

Audit Conduct

Pharmacovigilance On site Audit usually starts with an introductory meeting followed by the review of the remaining relevant documents and interviews with the relevant personnel. The next step would be the demonstration of the PV activity and a tour of the facility. Finally, the audit will end with a closing meeting where the initial audit results will be presented.

Audit Report

An initial audit report is generally issued within defined timelines and specifies which topics have been audited with a detailed description of the findings detected, together with an Executive Summary. A significance rating and proposed actions are generally included for each finding identified. The initial report may be reviewed by Auditees and or Quality Assurance department prior to the issue of the final audit report which includes the development and implementation Corrective And Preventative Action Plans (CAPAs). Dr. Haney Pharma can provide an Audit Certificate if required to confirm that the Audit was performed.

Audit Follow up and Closure

The client’s Quality Assurance department monitors the development and implementation of CAPAs plans. The audit is closed when applicable CAPAs have been completed.

This post is also available in: German