Audit and inspection are two critical components of quality assurance in the pharmaceutical industry. Both are essential for ensuring compliance with regulatory requirements and for identifying areas where improvements can be made in quality systems. An audit is a systematic and independent examination of a company's quality system to determine whether it meets the requirements of applicable regulations and standards. The audit process involves reviewing documentation, procedures, and practices to identify potential areas of non-compliance and areas for improvement. The audit can be internal, where a company audits its own quality system, or external, where an independent third-party audits the quality system. Inspection, on the other hand, is a regulatory process conducted by government authorities to ensure that a company's quality system is compliant with regulations and standards. The inspection process involves a review of a company's facilities, procedures, and documentation to determine whether they meet regulatory requirements. Inspections may be conducted on a routine basis or may be triggered by specific events, such as a product recall or a serious adverse event. During an audit or inspection, the auditors or inspectors will typically review a range of documents and processes, including: Standard operating procedures (SOPs) for quality control and quality assurance Documentation of manufacturing processes and quality control testing Personnel training records and qualifications Equipment and facility maintenance and cleaning records Complaint and deviation handling procedures Batch records and release testing The goal of an audit or inspection is to identify any deficiencies in the quality system that could impact product quality or patient safety. Depending on the severity of any non-compliance identified, regulatory action may be taken, such as issuing a warning letter or suspending a company's manufacturing license. Overall, audits and inspections play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products, and are an essential part of the regulatory process for the pharmaceutical industry.

1. Welcome
AUDIT AND INSPECTION
K. Supriya
Pharm-D
030/022023
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2. Index
AUDIT
 Aim
 Strategic level audit planning
 Tactical level audit planning
 Operational level audit planning
 Reporting
INSPECTION
 Objective
 System and product-related inspections
 Routine and “for cause” pharmacovigilance inspections
AUDIT vs. INSPECTION
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3. AUDIT
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DEFINTION
Definition
Definition: A systematic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data were
recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating
procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
AIM: To use objective evidence to assess the appropriateness and effectiveness of the
implementation and operation of a pharmacovigilance system. The audit must be clearly
documented and can only rely on verifiable evidence, such as written records and statements.

4. The risk-based approach to
pharmacovigilance audits
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The risk can be
assessed at the
following steps
Strategic
level audit
planning
Tactical level
audit
planning
Operational
level audit
planning

5. The risk can be assessed at the following stages
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 Strategic level audit planning “Audit strategy” (long term approach), which should be endorsed by
upper management.
 Tactical level audit planning “Audit program”, setting audit objectives, and the extent and
boundaries, often termed as scope, of the audits in that program.
 Operational level audit planning “Audit plan” for individual audit engagements, prioritizing audit
tasks based on risk and utilizing risk-based sampling and testing approaches, and reporting of audit findings
in line with their relative risk level and audit recommendations in line with the suggested grading system.
Strategic level audit planning
The quality system for pharmacovigilance activities.
Interactions and interfaces with other departments, as appropriate.
pharmacovigilance activities conducted by affiliated organizations or activities delegated to another
organization (e.g. regional reporting centers, MAH affiliates or third parties, such as contract organizations
and other vendors).

6. Cont…
 This is a non-prioritized, non-exhaustive list of examples of risk factors that could be considered for the purpose of a
risk assessment.
 Changes to legislation and guidance.
 Risk to availability of adequately trained and experienced pharmacovigilance staff, e.g.( due to significant turn-over of
staff, deficiencies in training processes, re-organization, increase in volume of work).
 Significant changes to the system since the time of a previous audit, e.g. introduction of a new database(s) for pv
activities or of a significant upgrade to the existing database(s).
 Medicinal product(s) on the market with specific risk minimization measures or other specific safety conditions such as
requirements for additional monitoring.
 For national medicines authorities: how critical is the area/process to proper functioning of the
pharmacovigilance system and the overall objective of safeguarding public health.
 For MAH: How critical is the area/process to proper functioning of the pharmacovigilance system. When deciding
when to audit an affiliate or third party, the marketing authorization holder should consider the nature and criticality of
the pv activities that are being performed by an affiliate or third party
on behalf of the MAH.
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7. Cont…
 If the area/process has previously been audited, the audit findings are a factor to consider when deciding when to
re-audit the area/process, including the implementation of agreed actions.
 Identified procedural gaps relating to specific areas/processes.
 Other information relating to compliance with legislation and guidance, for example:
for national medicines authorities: information from compliance metrics from complaints, from external sources, e.g. audits.
 Other organizational changes that could negatively impact on the area/process, e.g. if a change occurs to a support function
(such as information technology support) this could negatively impact upon pharmacovigilance activities).
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8. Tactical level audit planning
The risk-based audit program should be based on an appropriate risk assessment and should focus on:
 The quality system for pharmacovigilance activities.
 Critical pharmacovigilance processes ( for example Module I ).
 Key control systems relied on for pharmacovigilance activities.
 Areas identified as high risk, after controls have been put in place or mitigating action taken.
 The risk-based audit program should also take into account historical areas with insufficient past
audit coverage, and high risk areas identified by and/or specific requests from management and/or
persons responsible for pharmacovigilance activities.
 The audit program documentation should include a brief description of the plan for each audit to be
delivered, including an outline of scope and objectives.
 The rationale for the timing, periodicity and scope of the individual audits which form part of the audit
program should be based on the documented risk assessment.
 However, risk-based pharmacovigilance audit(s) should be performed at regular intervals, which are in line with
legislative requirements. Changes to the audit program may happen and will require proper documentation.
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9. Operational level audit planning and reporting
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The organization
should ensure
that written
procedures are in
place regarding
the planning and
conduct of
individual audits
that will be
delivered.
Time frames for
all the steps
required for the
performance of
an individual
audit should be
settled in the
relevant audit
related
procedures
The organization
should ensure that
audits are
conducted in
accordance with
the written
procedures, in line
with this GVP
Module.
Individual PV
audits should be
undertaken in line
with the approved
risk-based audit
program.
When planning
individual audits,
the auditor
identifies and
assesses the risk
relevant to the
area under review
The auditor
also employs
the most
appropriate
risk-based
sampling and
testing
methods,
documenting
the audit
approach in
an audit plan

10. Reporting
• The findings of the auditors should be documented in an audit report and should be communicated to
management in a timely manner.
• The audit process should include mechanisms for communicating the audit findings to the auditee and receiving
feedback, and reporting the audit findings to management and relevant parties, including those responsible for
pharmacovigilance systems, in accordance with legal requirements and guidance on pharmacovigilance audits.
• Audit findings should be reported in line with their relative risk level and should be graded in order to indicate
their relative criticality to risks impacting the PV system, processes and parts of processes.
• The grading system should be defined in the description of the quality system for PV, and should take into
consideration the thresholds noted below which would be used in further reporting under the legislation.
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11. Cont…
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CRITICAL is a fundamental
weakness in one or more
pharmacovigilance
processes or practices
that adversely affects the
whole pharmacovigilance
system and/or the rights,
safety or well-
being of patients, or that
poses a potential risk to
public health and/or
represents a serious
violation of applicable
regulatory requirements
MAJOR is a significant
weakness in one or more
pharmacovigilance processes or
practices, or a
fundamental weakness in part of
one or more pharmacovigilance
processes or practices that is
detrimental to the whole process
and/or could potentially
adversely affect the rights, safety
or
well-being of patients and/or
could potentially pose a risk to
public health and/or represents a
violation of applicable regulatory
requirements which is however
not considered serious
MINOR is a weakness in
the part of one or more
pharmacovigilance
processes or practices
that
is not expected to
adversely affect the whole
pharmacovigilance
system or process and/or
the
rights, safety or well-being
of patients

12. Inspection and its types
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Definition: Pharmacovigilance inspections are conducted to ensure that requirements for monitoring the safety
of medicines are met. The responsibility for carrying out the inspections rests with the national competent
authorities.
Objectives
• To determine that the marketing authorization holder has personnel, systems and facilities in place to meet
their pharmacovigilance obligations.
• To identify, record and address non-compliance which may pose a risk to public health.
• To use the inspection results as a basis for enforcement action.
Inspection types: System and product-related inspections
Pharmacovigilance system inspections are designed to review the procedures, systems, personnel, and
facilities in place and determine their compliance with regulatory pharmacovigilance obligations. As part of this
review, product specific examples may be used to demonstrate the operation of the pharmacovigilance system.
Product-related pharmacovigilance inspections are primarily focused on product-related pharmacovigilance
issues, including product-specific activities and documentation, rather than a general system review. Some
aspects of the general system may still be examined as part of a product-related inspection (e.g. the system used
for that product.

13. Routine and “for cause” pharmacovigilance
inspections
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Definition: Routine pharmacovigilance inspections are inspections scheduled in advance as part of
inspection program. There is no specific trigger to initiate these inspections, although a risk-based approach
to optimize supervisory activities should be implemented.
For cause inspections may arise when, for example, one or more of the triggers listed below are identified:
• risk-benefit balance of the product:
− change in the risk-benefit balance where further examination through an inspection is considered
appropriate.
− delays or failure to identify or communicate a risk or a change in the risk-benefit balance.
− communication of information on pharmacovigilance concerns to the general public without giving prior or
simultaneous notification to the national competent authorities or Agency, as applicable.
− non-compliance or product safety issues identified during the monitoring of pharmacovigilance activities by
the national competent authorities and/or the Agency.
− suspension or product withdrawal with no advance notice to the competent authorities.

14. Cont…
reporting obligations (expedited and periodic):
− delays or omissions in reporting.
− poor quality or incomplete reports.
− inconsistencies between reports and other information sources.
requests from competent authorities:
− failure to provide the requested information or data within the deadline specified by the
competent authorities.
− poor quality or inadequate provision of data to fulfill requests for information from the competent authorities.
fulfillment of commitments:
− concerns about the status or fulfillment of risk management plan (RMP) commitments.
− delays or failure to carry out specific obligations relating to the monitoring of product safety, identified at the
time of the marketing authorization.
− poor quality of reports requested as specific obligations.
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15. Audit vs. Inspection
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16. References
1) https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-
module-iii-pharmacovigilance-inspections_en.pdf
2) https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-
gvp-module-iv-pharmacovigilance-audits-rev-1_en.pdf
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17. Thank You!
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