STES’s
SMT. KASHIBAI NAVALE COLLEGE OF PHARMACY
Diploma Course in Pharmacovigilance
QUALITY MANAGEMENT SYSTEM
Guidance document
for MAH released by PVPI
PRESENTED BY-GROUP 5
Ms. Alfiya Tamboli
Mr. om bhalerao
Ms. Rohini Rathod
Ms. Vaishnavi Gondre
Ms. Pooja lohakare
1
Marketing Authorization
Holder
• A Market Authorization Holder
(MAH) is a legal entity • Pharmacovigilance System Master File
Mo
responsible for the marketing dul
e1
and distribution of a
medicinal product within a • Collection, Processing & Reporting of Individual Case
Mo
specific territory. dul Safety Report
e2
• The MAH holds the official • Preparation & Submission of Periodic Safety Update
approval from a regulatory mo
dul Report
authority, such as the e3
European Medicines Agency • Quality Management System at MAH's
Mo
(EMA) in the EU or the Food dul organization
and Drug Administration e4
• Audits and Inspections of Pharmacovigilance systems at
(FDA) in the U.S., to sell the
Mo MAH's
product in that market dul
e5
• This authorization is granted
after a thorough evaluation of Mo • Submission of Risk Management Plan
dul
the product's safety, efficacy, e6
and quality.
2
Scope and Responsibilities of MAH
SCOPE : RESPONSIBILITIES IN :
New Drugs and Subsequently Regulatory compliance
approved drugs
Pharmacovigilance
Biologics
Quality assurance
Radiopharmaceuticals
products Labelling and packaging
Phytopharmaceuticals Product Post authorization changes
33
Module 4: QMS
INTRODUCTION
This module contains guidance for the Marketing Authorization Holders for the
establishment, maintenance, performance and quality assurance of PV system.
SCOPE
This guidance document is applicable to all MAHs who hold marketing
authorization for manufacture or import of pharmaceutical products in Indian
market.
STRUCTURE AND PROCESS
1. Pharmacovigilance system
A PV system is defined as a system used by MAH to fulfil its legal tasks and responsibilities
in relation to PV and designed to monitor the safety of pharmaceutical products approved
by appropriate licensing authorities in India and to detect any change to their benefit-risk
balance. This system should cover MAHS organizational structure
i.e. organogram describing PV personnels roles and responsibilities, procedures, processes
and resources of the PV system as well as appropriate resource management,
4 compliance
management and record management 4
Quality management is based on following activities
Quality
Quality Quality
QC and QA improveme
planning adherence
nt
2. Training of MAH personnel
a. Initial, continued training or induction programme within one month of joining
b. keep training plans and records for maintaining documentation
3. Facilities and equipment
c. It include office space, Information Technology (IT) systems and storage space
(electronic).
d. Located, identified, designed, constructed, adapted and maintained to suit their
intended purpose in line with the quality objectives for PV System.
e. Facilities and equipment which are critical for the conduct of PV should be subject to
appropriate checks, qualification and/or validation activities to prove
. their suitability for
the intended purpose.
5
Responsibilities for quality system within organization
Responsibilities on Responsibilities On Managerial
MAH Staff:
Is To Provide: Document
Audit Documentati
quality
performance on control
system
sufficient staff for
PV
Record Providing
Assigning
managemen resource and
roles to staff
t training
Problem Compliance
Enough qualified solving of guidelines
staff
6
Specific quality system procedure and management
Compliance management by MAH
For the purpose of compliance management, MAH shall have specific quality
system procedure and process in order to ensure the following:
Continuous
COMPLIANCE MANAGEMENT
monitoring of PV data
Scientific evaluation of
information
Submission of data
Effective
communication with
regulatory authority 7
6
Specific quality system procedure and management
Record management
The MAH shall record all PV
The hard copies should be
information and ensure that is
retained for a minimum of 10
handled and store so as to
years and soft copies to be
allow accurate reporting and
stored indefinitely.
verification of that information
Documentation of quality system
Record of :
deficiencies and reports of
management policy equipment
deviation 8
Specific quality system procedure and management
Adverse
Critical PV Event
Reporting
process
Quality Case
AIMS to systematically Managem Processin
monitor, evaluate and ent g
report AE to regulatory
authorities and ensure the KEY
safety and risk balance COMPONEN
TS
profile of the product.
Regulator
Key components y
Signal
of critical PV Detection
Reporting
process
Risk
Managem
ent
8
9
Specific quality system procedure and management
Monitoring the effectiveness of a quality management system (QMS)
in pharmacovigilance is crucial for ensuring patient safety and regulatory
compliance.
The QMS in PV should be continuously monitored for its effectiveness by the
MAH through the following processes:
• System reviews by those responsible for management
• Audits
• Compliance monitoring
• Inspections
• Evaluating the effectiveness of actions taken with pharmaceutical products
for the purpose of minimizing risks and supporting their safe and effective
use in patients.
The organization may use performance indicators to continuously monitor
the good performance of PV activities in relation to the quality 10
requirements. 9
Reference
Pharmacovigilance Guidance Document for Marketing Authorization Holders
of Pharmaceutical Products Published by; National Coordination Centre-
Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission
in collaboration with Central Drugs Standard Control Organization, Ministry
of Health & Family Welfare, Government of India version:1.0
Pharmacovigilance Guidance Document for Marketing Authorization Holders
of Pharmaceutical Products Published by; National Coordination Centre-
Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission
in collaboration with Central Drugs Standard Control Organization, Ministry
of Health & Family Welfare, Government of India Version: 2.0
11
10
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