Pharmacovigilance Audits: A Comprehensive Overview of Processes

This report provides a comprehensive overview of pharmacovigilance audits, essential for maintaining quality management systems in pharmaceutical organizations. It emphasizes the importance of audits in ensuring regulatory compliance, identifying quality improvements, and increasing leadership awareness. The report details the audit process, including planning and preparation, audit conduct, reporting and follow-up, and the critical role of Corrective and Preventive Action (CAPA). It highlights the use of risk-based planning to develop audit strategies and the significance of each step in ensuring the effectiveness of a pharmacovigilance program. The report also outlines the key processes that can be part of a routine pharmacovigilance audit, such as the interaction between medical information and drug safety, screening of literature, and management of safety in clinical trials. The conclusion reiterates the significance of pharmacovigilance audits as a crucial component of a pharmaceutical company's quality management system. It also highlights the role of pharmacovigilance audits in pharmacoepidemiology, the study of the effects of a drug in a population.

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Pharmacovigilance Audits
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Table of Contents
Introduction................................................................................................................................2
Steps involved in pharmacovigilance audit................................................................................3
Planning and preparation........................................................................................................3
Audit conduct.........................................................................................................................4
Reporting and follow up.........................................................................................................5
CAPA.....................................................................................................................................5
Conclusion..................................................................................................................................6
References..................................................................................................................................8

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Pharmacovigilance Audits
Introduction
Pharmacovigilance audits are the essential component of every pharmaceutical organization’s
quality management system. If it is conducted correctly, it can provide an impartial opinion
of operational presentation of pharmacovigilance system, comparing the system against its
own methods and regulatory guidelines. It makes sure that the system remains compliant with
regulations 1.
Pharmaco-epidemiology is defined as the study of the drugs used in a large population1. The
pharmaco-epidemiological studies use pharmacokinetics and pharmacodynamics of a
diseased person to predict the effects of the drugs on patient 2.
The objective of a pharmaceutical audit is to evaluate the arrangement in a place to meet the
regulatory needs applicable to systems of pharmacovigilance (PV). The audit also verifies
that whether the arrangements are properly and consistently implemented, and
appropriateness of the documentation.
Importance of a pharmacovigilance audit
 To make sure compliance with organization procedure and global or local regulatory
requirements
 To Make sure company regulatory criteria’s are met
 To evolve regulatory needs
 To increase regulatory inspection of risk
 To identify quality improvements
 The most effective PV audits contribute to find-out and rectified the compliance
issues or adverse events in a cost-effective and well-planned manner 3.

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 The pharmacovigilance audits can be used as the vehicle to increase the leadership
awareness about the opportunities to make the company a more compliant firm 4.
Strategies to plan pharmaco-vigilance audit
 The main aim of developing a pharmacovigilance audit is to use the evidence to
examine the effectiveness of a PV program. For this, the manufacturers required to
use a risk-based planning to develop an audit strategy.
 The risk planning process should include all the pharmacovigilance methodologies
and activities.
 The structure and staff should be changed if necessary.
 For a pharmacovigilance audit, the strategic planning includes risk-based planning.
 The developers should establish and PV audit strategy which is approved by the upper
management 5.
Steps involved in pharmacovigilance audit
There are five steps of conducting a pharmacovigilance audit
1. Planning and preparation
2. Conduct
3. Reporting & Follow-up
4. CAPA
Planning and preparation
Planning an audit is the first step in order to prepare for pharmacovigilance audit. In this step
the pre-audit meetings conducted to understand responsibilities and organization and to the
scope of the process, to make agreement and development of an audit strategy which defines
the objectives, roles/ responsibility, and scope and to provide a framework for the regulatory

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environment and the audit conduct strategies such as sampling strategy and interviews. The
development and agreement of the agenda define the topics and individuals involved 6. Some
of the processes that can be good practices for a routine pharmacovigilance audit are:
 The interaction between medical information organization and the drug safety
 Screening of literature
 Managing the processes related to safety in a clinical trial
 Submission and processing of the specific cases
 Management and signal detection
 Core safety information
 Maintain the approved information about the product
 Training
 Validation of computer systems, back-ups, and security.
The estimated cost of the audit depends on the number of the topics included in the audit
scope and can be chosen based on their relevance to the company or organization. A regular
pharmacovigilance audit is conducted in less than 6 days.
Pre-audit questionnaires can also be used to gather the information, which can be used to
describe the proposed agenda and to conduct audit more efficiently. For a for each
pharmacovigilance audit, a detailed agenda is designed to facilitate the aspects of the audit 7.
Audit conduct
To start an audit opening or introductory meeting takes place. It also includes document
reviewing, activity demonstration such as processing of the AE (adverse event), the tour of
the facilities like work areas and file storage. Closing and exit gatherings to discuss the
preliminary results and follow-up of the outstanding questions or requests. This step not only
includes the relevant SOPs of the organization but also documents like PV agreement and the

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marketing partners. This increases the awareness about the company process and saves the
time for actual audit conduct which ultimately contributes to making the audit most efficient
8.
Reporting and follow up
The report of the audit is released within the pre-defined timeline, which includes an
executive summary, scope, and description of the objectives of the audit. It also reports about
the observations such as the description of the events observed, references and criteria used
for the observation, analysis of the effects and causes of the conditions and judgment or
rating such as critical, minor and major based on the companies rating scale. The report also
contains the process and opportunities for quality improvements. The report of the audit
generally describes the topics that have been covered during the pharmacovigilance audit
with the issues detected. A draft report can also be reviewed by the Auditees and the quality
assurance manager or personnel before releasing the final report. To confirm that the audit
has been conducted a certificate can also be issued.
CAPA
Corrective and preventing action or CAPA takes place to understand the observations
mentioned in the report and to seek the clarification as required and to assess the root cause
or underlying cause issue 9. For this the CAPAs should be:
 Specific: to resolve the adverse events and prevent their occurrence
 Achievable: a realistic action and in accordance with rules and regulations
 Time-driven: should identify the realistic timeframe to complete the task
 Accountable: actions that have clear accountability
Development of CAPAs is considered as one of the most essential aspects in order to
generate the successful audits and produced from the results or findings of the inspection and

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audits. The inspections are maintained and regulated by the regulatory authorities and audits
are conducted internally or external party. It is also sometimes called Corrective Action Plans
(CAPs). The periodic follow-up on the open CAPAs until closure, this can be risk-based. The
confirmation or verification may be needed to determine the completion. Audit closure takes
place when the applicable CAPAs are completed. To build the culture continuous
improvement and inspection readiness the audit experience can be used 10.
If the audits and inspections examine the non-functional part of the pharmacovigilance
system and issues, then CAPs describes:
 The details understanding of how a company can rectify the individual issues
 The detailed knowledge of the timescale and the process by which the issues can be
solved
 Explain in detail that how those strategies relate to and help to the pharmacovigilance
system
The serious event case study is submitted to a regulatory authority which is outside the legal
timescale, inspection, and triggering. An adequate response from the company is required for
the results of the inspection, in the form of Corrective and preventing action. This will
address the issues within PV operations associated with the delay 11.
Conclusion
Pharmacovigilance audits are considered as the important components of each
pharmaceutical company's quality management system. It is a part of pharmacoepidemiology,
which is the study of the effects of a drug in a population. The PV audits are important to
ensure that the regulatory criteria of a company are met, to find out the improvement, to
evaluate the regularity requirements and to rectify the issues by using money-saving

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strategies. A PV audits conducted in four steps that are planning and preparation, conduct,
reporting and follow-up and CAPA. The first step takes place to understand the roles and
responsibility, the scope of the methodologies and to make written agreements. Audit
conducting step starts with meetings and reviewing the documents and the demonstrated
activities. After the audit conduct reporting and follow up takes place to make a report of the
whole pharmacovigilance audit. In that report executive summer, scope and objective
descriptions are included. Coercive and preventing actions or CAPA is developed for
understanding the findings of the report.

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References
1. Pharmacovigilance [document on the Internet]: primevigilance; 2018 [cited 2018 July
08]. Available from:
http://www.primevigilance.com/pharmacovigilance-services/support-services/
pharmacovigilance-audit/
2. West-Strum D. Chapter 1 introduction to pharmacoepidemiology [documented on the
internet]: Access Pharmacy; 2011 [cited 2018 July 08]. Available from:
https://accesspharmacy.mhmedical.com/content.aspx?
bookid=515&sectionid=41502851
3. Guidelines on good pharmacovigilance practices (GVP): Module 4
pharmacovigilance audits [documented on the internet]: Heads of medicine Agencies;
2012 [cited 2018 July 08]. Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/
2012/07/WC500130395.pdf
4. Clement J. P. PV audit by Quality: friends and foes? [Documented on the internet]:
Pharma Elsevier; 2017 [cited 2018 July 08]. Available from:
https://pharma.elsevier.com/pharmacovigilance/pv-audit-quality-friends-foes/
5. The basics of pharmacovigilance audit [documented on the internet]: the FDA group;
2014 [cited 2018 July 08]. Available from: http://www.thefdagroup.com/thefdgroup-
blog/2014/11/pharmacovigilance-audits/
6. Carson, Phillip A., Dent Nigel J. Good clinical, laboratory and manufacturing
practices: techniques for the QA professional: Cambridge, UK: Royal Society of
Chemistry.2007.

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7. The audit process [documented on the internet]: PV focus; 2014 [cited 2018 July 08].
Available from: http://www.pvfocus.com/audit-process
8. Karen. 5 step to a successful safety audit [documented on the internet]: Newpig;
2018[cited 2018 July 08]. Available from: https://www.newpig.com/expertadvice/5-
steps-to-a-successful-safety-audit/
9. Corrective and preventive action-background and example [documented on the
internet]: U.S. food and drug administration; 2012 [cited 2018 July 08]. Available
from: http://fmdic.org/wp-content/uploads/2012/05/Lewandowski-CAPA.pdf
10. 5 steps to ensuring CAPA compliance [documented on the internet]: the FDA group;
2017 [cited 2018 July 08]. Available from: http://www.thefdagroup.com/thefdgroup-
blog/5-steps-to-ensuring-capa-compliance
11. What is a CAPA and why is it required? [Documented on the internet]:
primevigilance; 2018 [cited 2018 July 08]. Available from:
http://www.primevigilance.com/pharmacovigilance-services/support-services/
corrective-and-preventative-actions/