Pharmacovigilance Function at SPL.pdf

TRAINING ON
MANAGEMENT OF
PHARMACOVIGILANCE
FUNCTIONS
Presented by:
MD ZAKARIA FARUKI
Head of Quality Assurance
Silva Pharmaceuticals Limited
Date of Training October 03, 2023
Silence Your
Cellphone
ONJOB
SOP No.: SOP/QA/045/01
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Pharmacovigilance (PV/ PVG) also known as drug safety, is the
pharmacological science relating to the collection, detection, assessment,
monitoring, and prevention of adverse effects with pharmaceutical
products. As such, pharmacovigilance heavily focuses on adverse drug
reactions, or ADRs, which are defined as any response to a drug which is
noxious and unintended, including lack of efficacy (the condition that this
definition only applies with the doses normally used for the prophylaxis,
diagnosis or therapy of disease, or for the modification of physiological
disorder function was excluded with the latest amendment of the
applicable legislation).
Medication errors such as overdose, and misuse and abuse of a drug as
well as drug exposure during pregnancy and breastfeeding, are also of
interest, even without an adverse event, because they may result in an
adverse drug reaction.
Information received from patients and healthcare providers via
pharmacovigilance reporting form as well as other sources such as the
medical literature, plays a critical role in providing the data necessary for
pharmacovigilance to take place. In fact, in order to market or to test a
pharmaceutical product m most countries, adverse event data received by
the license holder (usually a pharmaceutical company) must be submitted
to the local drug regulatory authority.
INTRODUCTION TO PHARMACOVIGILANCE ONJOB
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL

Adverse event is any untoward medical occurrence in a patient or
clinical investigation subject administered a pharmaceutical
product and which does not necessarily have a causal
relationship with this treatment. An adverse event (AE) can
therefore be any unfavourable and unintended sign (including an
abnormal laboratory finding), symptom, or disease temporally
associated with the use of a medicinal (investigational) product,
whether or not related to the medicinal (investigational) product.
AEs in patients participating in clinical trials must be reported to
the study sponsor and if required could be reported to local ethics
committee. Adverse events categorized as "serious" (results in
death, illness requiring hospitalization, events deemed life-
threatening, results in persistent or significant disability/
incapacity, a congenital anomaly/ birth defect or medically
important condition) must be reported to the regulatory
authorities immediately, whereas non-serious adverse events are
merely documented and sent to the regulatory authority.
ADVERSE EVENT (AE) ONJOB
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The amount and variety of safety-relevant data gathered from
different patient populations in global clinical trials are enormous;
therefore it is crucial that a concise and systematic approach to
pharmacovigilance be implemented. Systematic safety monitoring
is needed to identify previously recognized and unrecognized
adverse drug reactions and to evaluate the safety and efficacy of
medicinal products during clinical trials and in the post marketing
period.
It is important that pharmacovigilance not be perceived as a
burden put upon the pharmaceutical product development
industry by the regulating bodies. Ongoing pharmacovigilance
should be understood as essential to the only appropriate way to
develop safe medicines, introduce them into the market, and have
them survive in the market once approved. Not only does the
failure to perform ongoing safety assessment activities increase
the chances of placing subjects at risk unnecessarily, it also
increases a company's risk of investing in the development of the
wrong molecules.
THE IMPORTANCE OF IMPLEMENTING:
A SYSTEMATIC PHARMACOVIGILANCE APPROACH
ONJOB
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An operational overview of pharmacovigilance begins with safety
information coming from a variety of sources, including clinical trials
data, safety call centers, spontaneous reports, and literature
searches, each of which has the potential to create an individual
case. Within the pharmacovigilance department each case is
processed, assessed as to its relationship (causality) to the
investigational product, and reported to the regulatory authorities and
other stakeholders, either as an expedited report or as part of an
aggregate report, based upon pharmacovigilance policies,
regulations, and guidance documents. In addition, each case becomes
part of the total safety data set for that medicinal product.
Aggregate data are systematically analyzed for safety issues and
assessed for benefit versus risk, and periodic safety update reports
(PSURs) are submitted to the regulatory authorities as additional
safety information is collected. This continues throughout the
product's life cycle. Safety findings are addressed in order to mitigate
risk. This may include modification to a clinical trial design, changes
in proposed labeling, implementation of a risk mitigation plan, or
discontinuation of development or use of a marketed product.
Operational overview of Pharmacovigilance ONJOB
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Flow Chart of PVG Function at SPL ONJOB
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Organogram of PVG Team at SPL ONJOB
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Now What We Practice at SPL with SOP/QA/045/01:
Management of Pharmacovigilance Function
2. Scope
This SOP applicable for the management of
Pharmacovigilance activity mediated by all types of
medicines which are manufactured by Silva
Pharmaceuticals Limited.
To monitor and management of
Pharmacovigilance activities and informing
to regulatory authority (DGDA) accordingly.
ONJOB
1. Purpose
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ONJOB
3. Responsibility
3.1 Head of Product Management Department will
act as Head of Pharmacovigilance and will monitor
the overall activities of Pharmacovigilance. Manager,
QA will act as a focal point of Pharmacovigilance
activities of Silva Pharmaceuticals Limited and shall
be responsible for receiving of suspected adverse
event from the field force/ patient/ physician/ clinic/
healthcare professionals etc. through PMD & Sales
personnel.
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ONJOB
3. Responsibility
3.2 Head of Quality Assurance/his designee will
check product quality if any adverse event is
reported and also give other technical support. He
will also provide adverse event (AE) report to
regulatory department if any report is received
including zero report.
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3. Responsibility
ONJOB
3.3 Head of Drug Regulatory Affairs/ his
designee shall sent adverse event (AE)
report to DGDA including zero report.
3.4 Officer or above of Quality Assurance
Department is responsible for proper
implementation of this SOP.
3.5 Head of Quality Assurance is responsible
for Regulatory Compliance and Approval this
SOP.
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Pharmacovigilance: Pharmacovigilance (PV) is defined as the science and
activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other drug-related problem.
Adverse Drug Reaction (ADR): An adverse drug reaction (ADR) is an
unwanted or harmful reaction experienced following the administration of
a drug or combination of drugs under normal conditions of use and is
suspected to be related to the drug. An ADR will usually require the drug
to be discontinued or the dose reduced. The study of ADRs is the concern
of the field known as Pharmacovigilance.
Suspected Adverse Event: Suspected adverse event is an event that may
be occurred due to adverse drug reaction, product quality problem or
medication error
DGDA: Directorate General of Drug Administration
HEALTCARE PROFESIONALS: For the purpose of suspected adverse event
healthcare professionals are defined as medically qualified persons such
as physicians, dentists, pharmacist, chemist, nurses etc.
FOCAL POINT: Focal Point is the key person who will be responsible for
collecting of any type of adverse event and He should have contact
number so that field force/ patient/physician/ other healthcare
professionals may contact with him at any time for informing about
adverse event.
4.0 Abbreviations and Definitions ONJOB
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ONJOB
5.0 Materials and Equipment
Not applicable
6.0 Precaution / Health and Safety
Considerations
6.1 During collection of information
regarding suspected adverse event, it
should be collected very carefully and
information must be authentic and
reliable.
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7.1 Reporting of Adverse Event
7.1.1 Field force will collect suspected adverse event report from
physicians/ patients/other healthcare professionals or they will fill up
the suspected adverse event reporting form as per DGDA approved
prescribed form (Annexure-I) which is attached with the SOP and will
send it to Focal Point. Physicians / patients/other healthcare
professionals may also submit report through telephone or email.
7.1.2 After receiving of adverse event, Head of Pharmacovigilance
team shall arrange a meeting in presence of all team members to
discuss about event and a team will be formed to investigate the
event and also to find out the root cause.
7.1.3 After investigation if it is found that the event is occurred due
to product quality problem then necessary CAPA to be taken to solve
the problem. If the event was not found regarding product quality
problem then QA personnel will prepare an approval note as per
Annexure-II and Head of QA & Head of Pharmacovigilance will
approve the note. Then finally it will be sent to regulatory affairs
department.
7.0 Procedure (Contd…) ONJOB
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7.1.4 Then Drug Regulatory Affairs department will send it
to drug administration and collect a receiving acknowledgement
paper from drug administration as per Annexure-III.
7.1.5 Then Drug Regulatory Affairs department will send a copy of
acknowledgement paper to QA department.
7.1.6 If no event received, a letter will be sent to drug administration
from QA through regulatory affairs department as per Annexure-III.
7.2 Recording of Adverse Event
7.2.1 After receiving any adverse event, QA shall give the entry in log
book as per Annexure-IV.
7.2.2 7.2.2 The numbering will be as follows
AE/XX/YY
AE=Adverse Event
XX= Serial Number of Adverse Event will started from 01
YY= Last two digit of current year
7.0 Procedure (Contd…) ONJOB
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ONJOB
• 8.0 Reference Document
8.1 WHO Good Manufacturing Practices Guideline
8.2 DGDA Guidelines
• 9.0 Annexure
• 9.1 Annexure-I: SUSPECTED ADVERSE EVENT MONITORING
FORM OF DGDA (SOP/QA/045/01/F01)
• 9.2 Annexure -II: APPROVAL NOTE OF SUSPECTED ADVERSE
EVENT MONITORING REPORT (SOP/QA/045/01/F02)
• 9.3 Annexure -III: ACKNOWLEDGEMENT LETTER
(SOP/QA/045/01/F03)
• 9.4 Annexure -IV: ADVERSE EVENT RECORDING LOG
(SOP/QA/045/01/F04)
Version
No.
Brief Reason for the
Revision
Effective
Date
Remarks
01. First Version 02/09/2023 -
10.0 Revision History
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11.0 Training
11.1 Head of Quality Assurance or His
Nominee is Responsible To Conduct a
Training Session on This SOP.
ONJOB
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ANNEXURE-I:
Suspected Adverse Event Monitoring Form ONJOB
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ANNEXURE-I:
Suspected Adverse Event Monitoring Form ONJOB
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ANNEXURE-II: Approval Note of
Suspected Adverse Event Monitoring Report ONJOB
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ANNEXURE-III:
ACKNOWLEDGEMENT LETTER ONJOB
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ANNEXURE-IV:
ADVERSE EVENT RECORDING LOGBOOK ONJOB
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ABBREVIATIONS ONJOB
DGDA : Directorate General of Drug Administration
QA : Quality Assurance
PD : Product Development
QC : Quality Control
PMD : Product Management Department
DRA : Drug Regulatory Affairs
PV/ PVG : Pharmacovigilance
AE : Adverse Event
ADE : Adverse Drug Event
SAE : Suspected Adverse Event
ADR : Adverse Drug Reaction
ADRM : Adverse Drug Reaction Monitoring
ADRAC : Adverse Drug Reaction Advisory Committee
TSC : Technical Standing Committee
CAPA : Corrective Action and Preventive Action

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Interactive Session ONJOB

Pharmacovigilance ONJOB
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Pharmacovigilance Function at SPL.pdf

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