A pharmacovigilance audit involves several key steps: (1) opening meetings with relevant personnel, (2) document reviews and interviews to evaluate processes for safety data collection, case assessment, and reporting, (3) analyzing data to identify potential safety signals, and (4) closing meetings to discuss preliminary findings. The audit aims to verify that the pharmacovigilance system meets legal requirements for drug safety monitoring and ensure any issues from previous inspections have been addressed. Regular audits are important for regulatory compliance and identifying areas for improvement in pharmacovigilance practices.

1. Describe the various steps involved in conducting a pharmacovigilance audit
1
Describe the various steps involved in conducting
a pharmacovigilance audit
Fernanda Ferreira, f.lima22
Student of Advanced Post Graduate Diploma in Pharmacovigilance & Medical Writing,
James Lind Institute, Mar-2016
The objective of this paper is to outline the various steps involved in conducting a pharmacovigilance
audit
Introduction
The safety of drugs is of paramount
importance to patients and healthcare
professionals. The pharmaceutical industry has
an ethical and legal responsibility to ensure
that the products they sell will not harm the
patients they are intended for. The
repercussions of a new drug having a
potentially serious side-effect profile are
enormous for patients, healthcare professionals
and the industry. Public pressure on industry
and regulatory bodies to improve the
monitoring of drug safety has led to greater
scrutiny of the groups responsible within
organizations, namely the pharmacovigilance
departments. Regulatory bodies do not have
the resources to closely monitor the safety of
all drugs that are licensed in their regions, and
rely on the industry to do this1
.
To ensure that the industry is meeting its legal
responsibilities, pharmacovigilance inspections
are held1
– the audit, that is conducted so as to
prepare for an inspection by a government
body, is an examination and verification of
processes, data, and documentation relating to
drug safety by a nongovernmental agency
(such as a business partner, contractor, internal
quality assurance group, etc) 2
.
Pharmacovigilance audit and its objectives
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. In general, an
audit is a systematic, disciplined, independent
and documented process for obtaining
evidence and evaluating the evidence
objectively to determine the extent to which
the audit criteria are fulfilled, contributing to
the improvement of risk management, control
and governance processes. Audit evidence
consists of records, statements or other
information, which are relevant to the audit
criteria and verifiable. Audit criteria are, for
each audit objective, the standards of
performance and control against which the
auditee and its activities will be assessed. In
the context of pharmacovigilance, audit
criteria should reflect the requirements for the
pharmacovigilance system, including its
quality system for pharmacovigilance
activities, as found in the legislation and
guidance3
.
Regulatory background
Marketing authorization holders (MAHs), or
companies with an approved clinical trial
application (CTA) in place may be subject to
inspection at any time. Most inspectorates
apply a risk assessment model to target limited
resources at the highest risk areas1
.
In the United States (US), laws governing
medicines are found in the Food Drug and
Cosmetic Act [21 U.S.C. 301 et seq.] as well
as other statutes. In addition to laws, the US
Food and Drug Administration (FDA) has the
power under law to create regulations, which
are published in the Federal Register and in the
Code of Federal Regulations. The FDA also
issues guidances, which specify the agency’s
current thinking and preferences on laws and

2. Describe the various steps involved in conducting a pharmacovigilance audit
2
regulations. While nonbinding, these
Guidances are generally followed by the
industry. European Union (EU) legislation is
more complicated than in the US, because it
derives from treaties and agreements between
27 different sovereign countries (Member
States). The EU pharmacovigilance laws are
specified in Regulations (laws directly
applicable to all Member States, without the
need for additional implementation at the
national level); and Directives (which bind
Member States to implement the contents of
the Directive into their national laws within a
certain time period). There are also guidance
documents on pharmacovigilance (which,
although not law themselves, should be
complied with), one such document being
Volume 9a of the Rules Governing Medicinal
Products in the European Union -
Pharmacovigilance. In the EU, the European
Medicines Agency (EMA) evaluates and
supervises the approval and use of medicinal
products that are centrally approved in the EU
(a process whereby a single application leads
to an EU-wide approval). In addition, products
that are not centrally approved are evaluated
and supervised either by individual national
regulatory authorities, or by a group of
member states’ regulatory authorities, with one
of the member states acting as the “reference
member state” and leading the process (known
as the decentralised or mutual recognition
procedures) 4
.
Example of auditing steps
• Opening / introductory meeting to "kick
off" the audit
• Interviews with relevant personnel
• Document reviews
• Demonstration of activities (e.g.
processing of an adverse event case)
• Tour of facilities (e.g. work areas, file
storage and archiving)
• Closing / exit meeting to discuss
preliminary results
• Follow-up on outstanding questions /
requests5
Audit process model
• Data collection: it might include checking
the processes of processing of Safety
Information, sources of Data, Safety Data
Exchange Agreements, outsourcing to
Contract Reasearch Organizations (CROs),
follow-up Data Collection, clear Definition
of Start Date to correctly determine the
reporting deadlines.
• Cases assessment: it might include who is
assessing cases, if are all cases medically
assessed, who is responsible for ensuring
the consistency of coding key data items.
• Report for regulatory: it might include if
all boxes been filled in correctly on
reporting form, if reporting deadlines have
been met, are metrics in place and
regularly reviewed to ensure reporting
deadlines are met, conductions a medical
review for consistency of source
documents, database records, and final
MedWatch/CIOMS reporting forms.
• Analyze to detect signals: ensure that
signaling and risk assessment activities are
conducted, process for escalation of safety
issues (including committees,
responsibilities, actions taken,
communication to regulatory authorities,
institutional review boards, and so on) and
if crisis management plans are in place.
• Additional items: review previous
audit/inspection reports to ensure that
follow-up commitments from previous
inspections have been met, standard
operation procedures and Work
Instructions, Personnel Files, Metrics,
Quality Systems, Vendors, Validation (
computer systems and business continuity
plans)2
, Personnel training and Archive/
Document storage Pharmacovigilance6
.
Additionally, a new tool, called the
“Pharmacovigilance System Master File”, is
aimed to contribute to the appropriate planning
and conduct of audits by the marketing
authorization holder and the supervision of
pharmacovigilance activities by the qualified
person responsible for pharmacovigilance7
.

3. Describe the various steps involved in conducting a pharmacovigilance audit
3
Conclusion
It is important to keep track of all audit and
inspection findings, ideally in a CAPA
(corrective action preventive action) system.
All findings should be monitored by the group
responsible for quality and progress in fixing
the problems2
.
Additionally, companies should ensure that
pharmacovigilance departments are audited on
a regular basis; this is not only a regulatory
requirement, but is also useful in identifying
any areas that could be a regulatory risk.
Exposure to interviews by auditors is also
good preparation for inspections, as it is the
process for understanding and responding to
audit findings. Companies should also
consider conducting “mock inspections” at
intervals to test their “inspection readiness”1
.
References
1. Fitzgerald P. Pharmacovigilance
inspections. Indian J Pharmacol. 2008; 40(1):
S21-S23.
http://www.ncbi.nlm.nih.gov/pmc/articles/PM
C3038520/. Accessed 08/03/2016.
PMC3038520.
2. Jolley S. G. Preparing for a Safety
Inspection. Drug Information Journal. 2011;
705–711.
http://cesruc.org/uploads/soft/130303/1-
130303193044.pdf. Accessed on 08/03/16.
3. Guideline on good pharmacovigilance
practices (GVP) - Module IV –
Pharmacovigilance audits (Rev 1). European
Medicines Agency website.
http://www.ema.europa.eu/docs/en_GB/docum
ent_library/Scientific_guideline/2015/08/WC5
00191778.pdf. Accessed 07/22/2016.
4. Global Monitoring of Medicine Safety.
http://www.pfizer.com/files/health/medicine_s
afety/2-
8_Global_Monitoring_of_Medical_Safety.pdf.
Accessed 08/03/2016.
5. Pharmacovigilance Risk Management Audit
[slide presentation].
http://pt.slideshare.net/clarityeye/audit-in-
pharmacovigilance. June 2010. Accessed on
08/03/2016.
6. Jadhav D. Pharmacovigilance Risk-Based
Audit Approach- Detailed summary (but not
limited to). Linked In website.
https://www.linkedin.com/pulse/pharmacovigil
ance-risk-based-audit-approach-detailed-
jadhav. October 2015. Accessed on 08/03/16.
7. Vergallo G. Recent Developments in EU
and US Pharmacovigilance Legislation. J
Pharmacovigilance. 2013.
http://www.esciencecentral.org/journals/recent
-developments-in-eu-and-us-
pharmacovigilance-legislation-2329-
6887.1000e105.php?aid=10921. Accessed
08/03/2016.