QUALITY MANAGEMENT

Total Quality Assurance in Pharmacy

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Wayan Redja
2018
 QUALITY MANAGEMENT

 INTRODUCTION
 QMS ISO 9001
 PHARMACEUTICAL QUALITY SYSTEM
 GMP FOR PHARMACEUTICAL PRODUCTS
 TOTAL QUALITY ASSURANCE IN PHARMACY

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 INTRODUCTION

 What is Quality Management?

 What is Quality Management System?
 What is Quality Assurance?
 Purpose of Quality Management
 Why Quality Management?
 Scope of Quality Management
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 TOTAL QUALITY MANAGEMENT (TQM)

INTERNAL
Employee, Owner
QMS: Org Chart, Process, Procedure, 5M
PROCESSES (Product Realization)
INPUT OUTPUT
Effective, Efficient > Productive Effectiveness
/ Efficiency

Productivity
SATISFACTION
ORGANIZATION QUALITY
ENVIRONMENT Continual
EXTERNAL Improvement
Customer
Supplier
Government
Other Clients
 What is Quality Management?

What is Quality?
 Ability to fulfill requirements
 Closeness to the standard
 Degree to which a set of inherent
characteristics fulfills requirements*
(ISO 9000:2005)

* Requirements
Need or expectation that is stated, generally
implied or obligatory

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 What is Quality Management?

What is Quality of Process?

Process Quality is Productivity

Effectiveness
Productivity = Efficiency

Effective, Efficient > Productive

Effectiveness, Efficiency > Productivity
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 What is Quality Management?

What is Management?

 Coordinated activities to direct and

control an organization (ISO 9000).

 Management functions:
- Planning, Organizing, Actuating, Controlling (POAC)
- Plan, Do, Check, Act (PDCA)

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 What is Quality Management?

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 What is Quality Management?

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 What is Quality Management?

 Quality Management
Management with regard to quality.

Coverage
- Quality Management System
- Quality Assurance

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 What is Quality Management System?

What is System ?

 System (ISO 9000)

Set of interrelated and interrelating elements.

Examples:
- Education System
- Health System
- Cardiovascular System
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 What is Quality Management System?

 Quality Management System (ISO 9000)

System with regard to Quality Management System.

Coverage
- Organization Structure
- Processes
- Procedures
- Resources

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 What is Quality Assurance?
Quality Assurance
 Part of Quality Management focused on providing confi-
dence that quality requirements to be fulfilled. (ISO 9000:2005)

 The activity of providing the evidence needed to establish

confidence, among all concerned, that the quality function
is being effectively performed. (J.M.Juran, 1988)

 A wide ranging concept covering all matters that individually

or collectively influence the quality of product. (WHO, 2007)

Note: QA is a system approach on preventing defect

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The Purpose of Quality Assurance

 To fulfill customer requirements

 To satisfy customer and other stake-holders
 To assure effectiveness, efficiency, and productivity
 To eliminate reprocesses
 To assure quality
 To be able to compete
 To maintain sustainability

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Why Quality Assurance?

 Customer requirements should be fulfilled.

 Customer requirements are changing.
 QA assists in enhancing customer satisfaction.
 QA provides confidence to its customers and the
organization.
 Competitive pressure
 Advances in technology
 QA provides the framework for continual
improvement.

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 Quality Assurance Principles?

Principles
 Make quality people before making quality product.
 To build quality into the product.
 Do it right from the first time and every time.
 Do what is written and write what is done.
 The 5 NOs: Don’t make, deliver, accept, keep or use defect
product.
 The next process is our customer.

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 Scope of Quality Management

 Good Manufacturing Practice for Pharmaceutical

Product (GMP = CPOB)
 Good Laboratory Practice (GLP)
 Good Storage Practice (GSP)
 Good Distribution Practice (GDP)
 Good Pharmacy Practice (GPP)

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QUALITY MANAGEMENT SYSTEM
ISO 9000

Modul-2

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 ISO QUALITY MANAGEMENT SYSTEM

 What is ISO?
 The ISO 9000 Family
 Quality Management Principles
 Process-based Quality Management System

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 QUALITY MANAGEMENT SYSTEM ISO 9000
The Process Based QMS
CONTINUAL IMPROVEMENT
OF THE QMS

Management CUSTOMER
(and other
Responsibility
interested
parties)
Measurement,
CUSTOMER Resource Analysis, SATISFACTION
(and other Management Improvement
interested
Product
parties)
Realization
INPUT PROCESSES OUTPUT
REQUIREMENTS 5M PRODUCT

Value-adding activities
Information flow
 QUALITY MANAGEMENT
The 8th Principles of QMS ISO 9000
• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Factual approach to decision making
• Mutually beneficial supplier relationships
• Continual improvement
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 QUALITY MANAGEMENT
Principles of Quality Assuranse?
• Do it right from the first time.
• Do what is written and write what is done.
• Make quality people before making quality product.
• Build quality into the product.
• The 5 NOs : Don’t make, deliver , accept, keep and
use defect product.
• The next process is our customer
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 QUALITY MANAGEMENT
What is Quality Assuranse?

 The totality of systematic actions necessary

to ensure adequate confidence that a
product (or service) will satisfy given
Note: requirements for quality.
QA is
a preventive
system Basic Principle: “Do it right
approach from the first time ,and every time.”
on defects
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 QUALITY MANAGEMENT
What is The Purpose of Quality Assurance?
 To fulfill customer requirements
 To satisfy customer and other stake-holders
 To assure effectiveness, efficiency, and productivity
 To eliminate reprocesses
 To assure quality
 To be able to compete
 To maintain sustainability
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 QUALITY MANAGEMENT
Why Quality Assurance?
 Customer requirements should be fulfilled.
 Customer requirements are changing.
 QA assists in enhancing customer satisfaction.
 QA provides confidence to its customers and the
organization.
 Competitive pressure
 Advances in technology
 QA provides the framework for continual improvement

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QUALITY MANAGEMENT
How to Apply Quality Management?
 Practice The 8th Principles of Quality Management.
 Practice The Principles of Quality Assurance.
 Practice The Management Functions (POAC or PDCA)
- Decide clear goal statement (SMART)
Plan - Plan activities for goal achievement
- Plan resources related to activities
- Do what is written and write what is done.
Do, Check, Act - IPC ( In Process Control)
- Take action for any discrepancies.
 Practice Management Review : - CAPA
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 SCOPE
Why Quality Assurance?
 Customer requirements should be fulfilled.
 Customer requirements are changing.
 QA assists in enhancing customer satisfaction.
 QA provides confidence to its customers and the
organization.
 Competitive pressure
 Advances in technology
 QA provides the framework for continual improvement

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 QUALITY MANAGEMENT SYSTEM ISO 9004
The Process Based QMS

CONTINUAL IMPROVEMENT OF THE QMS

Leadng to Sustained Success
C4
Managing for The
Sustained Success C9
C5 Imprmnt
REQUIREMENTS Strategy C4 Innov &
& Policy Management Learning
Responsibility
C8
C6 C6 C8
CUSTOMER Monitor,
Resource Resource Measurement, CUSTOMER
(and other Measure
Mgt Management Analysis, (and other
interested Analysis interested
C7 Improvement
parties) & Review parties)
Product
INPUT Realization OUTPUT
5M PRODUCT SATISFACTION
PROCESSES
Value-adding activities C6
Information flow
Process Mgt
 Good Manufacturing Practice
in Pharmacy
 Pharmaceutical Quality System: ICH Q10 PQS
 Scope: CPOB,CPBBOB, CPOTB, CPKB
 What is GMP of Pharmaceutical Product (CPOB)
 Why CPOB? Errors in CPOB
 Purpose of CPOB
 Processes and Resources in CPOB
 Critical Supporting Facilities in CPOB
 How to Implement CPOB – Principles
 Documentation
 Quality Audit and Annual Product Review
 Management Review and Continual Improvement
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Product realization in GMP of
Pharmaceutical Product

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 ICH Q10 PQS
Pharmaceutical Technology Commercial Product
Development Transfer Manufacturing Discontinuation
Investigational Product
GMP
Management Responsibilities
Process Performance & Product Quality Monitoring System
PQS CA/PA System, Change Management System,
Elements Management Review

Knowledge Management
Enablers* ty
Quality Risk Management
 Good Trade and Distribution Practice
 Scope
 What is GTDP
 Why GTDP
 Purpose of GTDP
 Processes and Resources in GTDP
 How to Implement GTDP- Principles
 Documentation
 Quality Audit
 Management Review
 Continual Improvement
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 Good Storage Practice
 Scope
 What is GSP
 Why GSP
 Purpose of GSP
 Processes and Resources in GSP
 How to Implement GSP- Principles
 Documentation
 Quality Audit
 Management Review
 Continual Improvement
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 Good Pharmacy Practice

 Scope
 What is GPP
 Why GPP
 Processes and Resources in GPP
 How to Implement GPP- Principles
 Documentation
 Quality Audit and Annual Product Review
 Management Review
 Continual Improvement
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THANK
YOU!!!