Quality Management System
By
TEAM PHARMAELITE
By NIPERians and ICTians, For Future NIPERians and ICTians!!
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Quality Management System
INDEX
Quality Cycle in GVP
Measuring Quality
Written Procedures
Purpose of Pharmacovigilance Training
Staff Training
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INDEX
Record Management System
Description of An Appropriate System
Documentation of Quality System
Quality Management Systems: FDA & EMA Requirements
Principles for Good Pharmacovigilance Practice (GVP)
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QUALITY MANAGEMENT SYSTEM
The Quality System is part of the Pharmacovigilance System and consists of its own structures and processes.
Marketing Authorization Holder (MAH) must have a quality management system in place to support
pharmacovigilance activities that have been implemented to meet pharmacovigilance legislation guidelines.
The Quality System covers the:
Organizational structure and Responsibilities.
Procedures and processes.
Resources and resource management.
Compliance management.
Record management.
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QUALITY CYCLE IN GVP
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QUALITY CYCLE IN GVP
1. Quality planning: Establishing structures and planning integrated and consistent processes (e.g., written SOPs)
2. Quality adherence: Carrying out tasks and responsibilities in accordance with quality requirements
3. Quality control and assurance: At every stage of case / process documentation should be verified for
compliance, quality and integrity of data (source data to be recorded and stored) Monitoring and evaluating
how effectively the structures and processes have been established and how effectively the processes are being
carried out (audit system)
4. Correcting and improving the structures and processes where necessary
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MEASURING QUALITY
1. Inspection.
2. Audit Quality Assurance.
3. Monitoring Quality Control.
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MEASURING QUALITY
Inspection: Official review of the PV system by a regulatory authority.
QA/Audit: Independent assurance that defined requirements for PV processes are followed. Provides a snapshot
rather than continuous footage.
QC/monitoring: Pivotal part of QMS to check and ensure by those performing, managing or supervising the PV
processes that required standards are met.
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WRITTEN PROCEDURES
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WRITTEN PROCEDURES
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PURPOSE OF PHARMACOVIGILANCE
TRAINING
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PURPOSE OF PHARMACOVIGILANCE
TRAINING
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STAFF TRAINING
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RECORD MANAGEMENT SYSTEM
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RECORD MANAGEMENT SYSTEM
The Record Management System should support:
Management of pharmacovigilance data quality:
a. Completeness of the data
b. Accuracy of the data
c. Integrity of the data
Timely access to all records.
Retention of documents relating to the pharmacovigilance system.
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RECORD MANAGEMENT SYSTEM
Retention of documents relating to the conduct of pharmacovigilance activities for individual vaccines.
Definition of applicable retention periods.
Specific measures for storage and processing of pharmacovigilance data to ensure data security and
confidentiality.
Ensure strict access to documents and database to authorized personnel.
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DESCRIPTION OF AN APPROPRIATE
SYSTEM
Responsibilities of the Qualified Person Responsible for Pharmacovigilance:
o Management of Pharmacovigilance Data
o Spontaneous Case Processing
o Reference Safety Information
o Literature review, including search strategy
o Periodic Safety Update Reports / Aggregate reports
o Signal management / Evaluation of Safety Data
o Risk Management / Minimization, incl. RMPs
o Clinical trials / observational studies, if applicable
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DOCUMENTATION OF THE QUALITY
SYSTEM
All elements, requirements and provisions adopted for the Quality System should be documented in a systematic
manner in form of written and version-controlled policies, procedures, quality plans, quality manuals and quality
records.
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DOCUMENTATION OF THE QUALITY
SYSTEM
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DOCUMENTATION OF THE QUALITY
SYSTEM
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
Both FDA and EMA (and other agencies) have made it clear that they expect quality to be built into drug safety (and
all pharmaceutical systems).
QMS:
I. Each company should have a quality management system (QMS) which includes a mission statement of the
goals and scope of the program as well as defining applicable laws, regulations and, importantly, best practices
(procedures where the law is unclear or silent).
II. In addition there should be written, versioned procedural documents (SOPs, Manuals, Work Instructions etc.).
III. It is a good idea to create a corporate “Quality Manual” summarizing, at a high level, the company’s intent to
maintain top quality.
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
Management Responsibility:
I. There must be a commitment by management for quality and they should lead by example.
II. They should communicate this policy, receive and respond to feedback and maintain a customer focus noting
that the concept of “customer” is broadly defined to include not just patients and health care providers but
many others such as health authorities, and internal company clients.
III. Management should ensure that planning and the quality system are put in place.
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
Management Responsibility:
I. There must be a commitment by management for quality and they should lead by example.
II. They should communicate this policy, receive and respond to feedback and maintain a customer focus noting
that the concept of “customer” is broadly defined to include not just patients and health care providers but
many others such as health authorities, and internal company clients.
III. Management should ensure that planning and the quality system are put in place.
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
Resource Management:
There must be adequate resources to get the job done and prevent backlogs.
This includes the usual things such as personnel, computers, work facilities, money/budgets etc.
There must be adequate training and the company must ensure that confidentiality and data privacy are fully
maintained.
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
Audits:
It is expected that all functions of PV (home office, subsidiaries, vendors, partners, etc.) should be audited
periodically.
FDA does not specify the frequency but many companies do audits of major operations yearly and smaller or less
critical PV units or functions every 2-4 years.
FDA and EMA maintain a 2-4 year inspection cycle of companies unless for cause when inspections are more
frequent.
There should be an internal company compliance function or group to handle this. They should not be part of PV
or drug safety.
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
European Medicines Agency:
EMA is more specific than FDA in noting that the MAH (sponsor) must have:
o Continuous monitoring of PV data, risk minimization.
o Scientific evaluation of all information on risks particularly regarding ARs from off-label or occupational exposure
o Examination & submission of non-serious ARs
o Integrity, quality & completeness of data
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
o Processes to avoid duplicate submissions.
o Effective communication with public, HCPs & CAs on all safety matters
o Updated product labeling as new information becomes known
o Written SOPs & procedural documents
o Good PV record management & data security/privacy
o Organization charts, HR management within PV, job descriptions
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
The EMA defines some “Critical PV processes”.
The implication of this is that they must be in place and will be inspected when the company gets a “visit “from a
health agency:
Continuous safety profile & benefit-risk evaluations
Establishing, assessing and implementing risk management systems and evaluating the effectiveness of risk
minimisation
Collection, processing, management, QC, follow-up for missing information, coding, classification, duplicate
detection, evaluation and timely electronic transmission of individual case safety reports (ICSRs) from any source
Signal management
PSURs
Meeting commitments and responding to requests from CAs;
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QUALITY MANAGEMENT SYSTEMS: FDA & EMA REQUIREMENTS
Interaction between the PV and product quality defect (i.e. manufacturing) systems
Communication of PV concerns between MAHs & CAs especially regarding changes to the risk-benefit balance of
products
Communicating information to patients and HCPs about changes to the risk-benefit balance
Keeping product information up-to-date
Implementation of variations (i.e. changes) to MAs for safety reasons according to the urgency required
Submissions to Eudra-Vigilance
The PV system must be continuously monitored with audits, KPIs and other procedures.
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PRINCIPLES FOR GOOD
PHARMACOVIGILANCE PRACTICE (GVP)
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PRINCIPLES FOR GOOD
PHARMACOVIGILANCE PRACTICE (GVP)
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By
TEAM PHARMAELITE
By NIPERians and ICTians, For Future NIPERians and ICTians!
Follow us on:
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