Insert lead inspector’s

competent authority logo /

emblem

PHARMACOVIGILANCE INSPECTION REPORT

Pharmacovigilance system name: Company Name:

PSMF :

Inspection number: PV 12345/0206INS/PHV/XXXX/XXX

[Enter EMA inspection reference number and/or

NCA inspection reference as applicable]

[Delete guidance notes and other non-applicable parts of this document before finalising]

Version number:
Date of issuance:
Table of contents
Abbreviations..............................................................................................3
SECTION A: Administrative information......................................................3
SECTION B: General information.................................................................3
B.1. Scope and reason for the inspection.............................................................................3
B.2. Reference texts and documents for the inspection...........................................................3
B.3. Conduct of the inspection with summary of the organisation and any significant changes and
action taken since the last inspection......................................................................................3
SECTION C: Inspected items.......................................................................3
SECTION D: Findings...................................................................................3
D.1. Definitions of inspection finding grading........................................................................3
D.2. Guidance for responding to inspection findings...............................................................3
D.3. Inspection findings.....................................................................................................3
D.3.1. Critical findings......................................................................................................3
D.3.2. Major findings........................................................................................................3
D.3.3. Minor findings........................................................................................................3
D.3.4. Comments.............................................................................................................3
SECTION E:.................................................................................................3
E.1 Conclusions...........................................................................................3
E.2 Recommendations.................................................................................3
E.3 Evaluation by the inspectors of the response from the inspectee..........3
E.4 Final conclusions and recommendations................................................3
SECTION F: Date and signatures of lead and other inspectors, experts if
applicable...................................................................................................3
APPENDIX I - Summary of items inspected -optional..................................3
APPENDIX II - Pharmacovigilance inspection plan......................................3
APPENDIX III - Closing meeting attendance record....................................3

Page 2/16
Abbreviations
ADR Adverse Drug Reaction

AE Adverse Event

CA Competent Authority

CAPA Corrective Action Preventive Action

CHMP Committee for Medicinal Products for Human Use

CRO Contract Research Organisation

CSR Clinical Study Report

CSU Central Safety Unit

EMA European Medicines Agency

GVP Good Vigilance Practice

ICH International Conference on Harmonisation

ICSR Individual Case Safety Report

IR Inspection Report

MAH Marketing Authorization Holder

PhV/PV Pharmacovigilance

PSMF Pharmacovigilance System Master File

PSUR Periodic Safety Updates Reports

QA Quality Assurance

QPPV Qualified Person for Pharmacovigilance

RA Regulatory Authority

SAE Serious Adverse Event

SAR Serious Adverse Reaction

SOP Standard Operating Procedure

SUSAR Suspected Unexpected Serious Adverse Reaction

TBA To Be Announced

Page 3/16
SECTION A: Administrative information

Inspection type: National routine, etc

Name and address(es) of

site(s) inspected:
Contact person: If different from QPPV

Date(s) of inspection:

Lead inspector if any:

Reporting inspector if any:

Accompanying inspector(s)
and experts:

Previous PhV inspections :

Date and competent authority

(inspectorates)

Purpose of inspection:

Products selected to provide As part of the general systems review, there are
system examples: products chosen for close evaluation of ADR reports,
PSURs, etc.
Note also: CAPs, MRPs, NAs as appropriate
Name and location of EU/EEA Name:
qualified person for Contact details:
pharmacovigilance:
Date of first issue of report to Date of submission
MAH:

Deadline for submission of

responses by MAH:
Date(s) of receipt of responses
from MAH:
Date of final version of report:
Report author: Name
Job title

Page 4/16
SECTION B: General information

B.1. Scope and reason for the inspection

System inspection or product inspection, or combined – supervisory authority inspection, local

inspection, particular focus, etc reasons for the inspection for the particular inspectee or any other
particular reason.

B.2. Reference texts and documents for the inspection

 Directive 2010/84/EU amending Directive 2001/83/EC

 EU Regulation 1235/10 amending Regulation (EU) No 726/2004
 Commission implementing Regulation 520/2012 on the performance of PhV activities
 Directive 2001/20/EC
 Directive 2005/28/EC
 CPMP/ICH/287/95: E2B (M) “Note for Guidance on Clinical Safety Data Management: Data
Elements for Transmission of Individual Case Safety Reports” and ICH E2B/M2 “Note for Guidance
on Electronic Transmission of Individual Case Safety Reports Message Specification”
 CPMP/ICH/288/95: E2C (R1) “Note for Guidance on Clinical Safety Data Management: Periodic
Safety Update Reports for Marketed Drugs”
 CPMP/ICH/3945/03: E2D “Post-Approval Safety Data Management: Definitions and standards for
Expedited Reporting”
 CHMP/313666/05: “Guideline on the exposure to medicinal products during pregnancy: need for
post-authorization data”
 CHMP/235910/05: “Guideline on conduct of pharmacovigilance for medicines used by the pediatric
population”

B.3. Conduct of the inspection with summary of the organisation and

any significant changes and action taken since the last inspection

The inspection was performed in accordance with the inspection plan (attached as Appendix II). If
necessary include the adjustments or changes.

A closing meeting was held to review the inspection findings, at place and date and attendance record
(Appendix III).

Brief summary of the pharmacovigilance system with presentation of changes, if any.

SECTION C: Inspected items

Refer to Appendix 1- Summary of items inspected.

SECTION D: Findings

D.1. Definitions of inspection finding grading

Critical (CR): a deficiency in pharmacovigilance systems, practices or processes that adversely affects
the rights, safety or well-being of patients or that poses a potential risk to public health or that
represents a serious violation of applicable legislation and guidelines.

Page 5/16
Major (MA): a deficiency in pharmacovigilance systems, practices or processes that could potentially
adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to
public health or that represents a violation of applicable legislation and guidelines.

Minor (MI): a deficiency in pharmacovigilance systems, practices or processes that would not be
expected to adversely affect the rights, safety or well-being of patients or pose a risk to public health.

Comment: the observations might lead to suggestions on how to improve quality or reduce the
potential for a deviation to occur in the future.

The factual matter contained in the inspection report relates only to those things that the inspection
team saw and heard during the inspection process. The inspection report is not to be taken as implying
a satisfactory state of affairs in documentation, premises, equipment, personnel or procedures not
examined during the inspection.

D.2. Guidance for responding to inspection findings

Responses to inspection findings should be clear, concise and include proposed actions to address both
the identified deficiency and the root cause of the deficiency. Consideration should also be given to
identifying and preventing other potential similar deficiencies within the pharmacovigilance system.

Responses should be entered directly into the table(s) in section D.3.1., without changes to the
inspectors’ text that describes the findings. The following text is intended as guidance when
considering the information that should be entered into each of the fields within the table(s). ‘Not
applicable’ should be entered into the relevant field if the requested information is not appropriate for
the finding in question.

Root cause analysis

Identify the root cause(s) which, if adequately addressed, will prevent recurrence of the
deficiency. There may be more than one root cause for any given deficiency.
Further assessment
Assess the extent to which the deficiency exists within the pharmacovigilance system and what
impact it may have for all products. Where applicable, describe what further assessment has
been performed or may be required to fully evaluate the impact of the deficiency e.g.
retrospective analysis of data may be required to fully assess the impact.
Corrective action(s)
Detail the action(s) taken / proposed to correct the identified deficiency.
Preventative action(s)
Detail the action(s) taken / proposed to eliminate the root cause of the deficiency, in order to
prevent recurrence. Action(s) to identify and prevent other potential similar deficiencies should
also be considered.
Deliverable(s)
Detail the specific outputs from the proposed / completed corrective and preventative
action(s). For example, updated procedure/work instruction, record of re-training, IT solution.
Due date(s)
Specify the actual / proposed date(s) for completion of each action. Indicate when an action is
completed.

Page 6/16
D.3. Inspection findings
.3.1. Critical findings
Present the critical findings as corresponding to the definition.

Finding Use the categories (and subcategories) listed in Appendix I followed by a

CR1 short title for the finding
<<Inspector to add text>>

References:

Directive 2001/83/EC as amended, Article 104(3).

Commission Implementing Regulation (EU) No. 520/2012, Article 10.

GVP Module xxx (as appropriate)
Add any local requirement (if appropriate)
Root cause analysis
<<MAH to add text>>

Further assessment
<<MAH to add text>>

Corrective action(s)
<<MAH to add text>>

Deliverable(s) Due date(s)

<<MAH to add text>> <<MAH to add text>>

Preventative Action(s)
<<MAH to add text>>

Deliverable(s) Due date(s)

<<MAH to add text>> <<MAH to add text>>

Recommendation / Observation (amend as necessary)

.3.2. Major findings

Present the major findings as corresponding to the definition

Finding Use the categories (and subcategories) listed in Appendix I followed by a

MA1 short title for the finding
<<Inspector to add text>>

References:

Directive 2001/83/EC as amended, Article 104(3).

Commission Implementing Regulation (EU) No. 520/2012, Article 10.

GVP Module xxx (as appropriate)
Add any local requirement (if appropriate)
Root cause analysis
<<MAH to add text>>

Page 7/16
 Further assessment
<<MAH to add text>>

Corrective action(s)
<<MAH to add text>>

Deliverable(s) Due date(s)

<<MAH to add text>> <<MAH to add text>>

Preventative action(s)
<<MAH to add text>>

Deliverable(s) Due date(s)

<<MAH to add text>> <<MAH to add text>>

Recommendation / Observation (amend as necessary)

.3.3. Minor findings

Present the minor findings as corresponding to the definition

Finding Use the categories (and subcategories) listed in Appendix I followed by a

MI1 short title for the finding
<<Inspector to add text>>

References:

Directive 2001/83/EC as amended, Article 104(3).

Commission Implementing Regulation (EU) No. 520/2012, Article 10.

GVP Module xxx (as appropriate)

Add any local requirement (if appropriate)

Root cause analysis

<<MAH to add text>>

Further assessment
<<MAH to add text>>

Corrective action(s)
<<MAH to add text>>

Page 8/16
 Deliverable(s) Due date(s)
<<MAH to add text>> <<MAH to add text>>

Preventative action(s)
<<MAH to add text>>

Deliverable(s) Due date(s)

<<MAH to add text>> <<MAH to add text>>

Recommendation / Observation (amend as necessary)

.3.4. Comments
Issues the inspectors would like to communicate to the inspectee– but that do not necessarily
represent any finding.

SECTION E:

E.1 Conclusions

E.2 Recommendations

E.3 Evaluation by the inspectors of the response from the

inspectee

E.4 Final conclusions and recommendations

SECTION F: Date and signatures of lead and other inspectors,

experts if applicable

Page 9/16
APPENDIX I - Summary of items inspected -optional
If the list of items covered during the inspection has been provided in section (B.1), Appendix I is
optional and may be deleted.

(Please enter, which areas were inspected during the inspection, if necessary enter comments or
specify).

Extent* Extent* Findings Comments

(Y/N)
Yes No
CR MA

1. QPPV
Qualifications
Job description
System oversight
Back-up process and
delegation
Others

2. PSMF
Format
Content
Maintenance and
submission
Others

3. Written
instructions (SOPs,
manuals, etc)
Procedures
Manuals
Process for SOP training
Others

4. Contracts,
agreements
Contracts
Agreements
Others
 
5. Periodic safety
update reports
PSUR scheduling
Format and content
Quality control of PSURs

Page 10/16
 Extent* Extent* Findings Comments
(Y/N)
Yes No
CR MA

Timeliness of
submission
Assessment report
comments
Others
 
6. Risk-management
system
Risk-management plan
format and content
Compliance with risk-
minimisation measures
which are beyond
routine
pharmacovigilance
Others
 
7. Management and
reporting of adverse
reactions
Receipt of ICSRs from
all sources and
collection and collation
at one point within the
EU
Assessments of
seriousness, causality
and expectedness
Medical review and
MedDRA coding
QC process
Submissions and follow
up processes
Reporting procedures
for PSP, PASS, PAES,
other non-interventional
trials
Literature screening
Others
 
8. Computerised
systems used for
pharmacovigilance

Page 11/16
 Extent* Extent* Findings Comments
(Y/N)
Yes No
CR MA

activities
Process for ensuring
computerised systems
Documentation of
fitness for purpose
Backup and disaster
recovery process
Process for migration of
database
Others
 
9. Clinical trials
SUSAR reporting
Consistency between
the IB and SPC when
marketed products are
used in CT
Reconciliation of SAEs
between clinical trial
and pharmacovigilance
databases.
Others
 
10. Signal
management
Dataset used for
conducting signal
detection (inclusion of
information from all
relevant sources)
Periodicity of data
review
Cumulative review
Process for further
validation and
investigation
Timely update of SmPCs
and PILs following signal
confirmation
Others
 
11. Product quality
Review of quality

Page 12/16
 Extent* Extent* Findings Comments
(Y/N)
Yes No
CR MA

complaints and trend

analyses
Reconciliation between
the complaints and
safety databases
Others
 
12. Archiving
Record management
Archiving facilities
Others
 
13. Quality
management system
Quality system and
compliance
management
Facilities and equipment
for pharmacovigilance
Audit (internal- and
external) and CAPA
process
Others

14. Training
Initial and on-going
training
Evaluation of training
Maintenance of training
records

15. Regulatory affairs

Creation and updates of
product information
Answer to questions
from competent
authorities

16. Medical
information
Reconciliation between
medical information

Page 13/16
 Extent* Extent* Findings Comments
(Y/N)
Yes No
CR MA

request and safety

database

17. Additional issues

if any
 

* Yes – this means an assessment of this area was undertaken that was considered sufficient by the
inspector to make an assessment of compliance and identify any issues.

No – this area was not looked at. This could be because it wasn’t necessary to address the scope of
the inspection or answer any concerns/questions in the inspection request.

A comment should be provided. This could be because it was not applicable.

Please note that the above items are not an exhaustive list, and other areas should be examined, as
appropriate to ensure the scope and objectives of the inspection are met.

Page 14/16
APPENDIX II - Pharmacovigilance inspection plan

{Add inspection plan}

Page 15/16
APPENDIX III - Closing meeting attendance record

Page 16/16