Modul-1

QUALITY ASSURANCE
 INTRODUCTION
 QUALITY MANAGEMENT
 GOOD MANUFACTURING PRACTICES
 GOOD TRADE AND DISTRIBUTION PACTICES
 GOOD PHARMACY PACTICE

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  INTRODUCTION

 Pekerjaan Kefarmasian da TQA

 What is Quality?
 What is Management?
 What is Quality Management?
 Why Quality Management?
 Purpose of Quality Management
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 TQA

“Selalu bekerja benar sejak awa!”

 Introduction
What is Quality?
 Ability to fulfill requirements
 Closeness to standard (specification)
 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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 Introduction
What is Quality?

QUALITY
Effective, Efficient > Productive
Effectiveness, Efficiency > Productivity
Effectiveness
Productivity =
Efficiency
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 Introduction
What is Management?

 Management (ISO 9000:2005)

Coordinated activities to direct and control
an organization.

Note: “ Management” sometimes refers to people at managerial level,

e.g. top, middle or lower management.

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 Introduction
What is Quality Management?
 Quality Management
- Management with regard to quality.
- Coordinated activities to direct and control
an organization with regard to quality.

Coverage
- Quality Management System (QMS)
- Quality Assurance (QA)

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 Introduction
Why Quality Management System?
 To enhance customer satisfaction.
 To provide confidence in fulfilling customer
requirements.
 Customer requirements are changing
 Competitive pressure
 Advances in technology
 To provide the framework for continual improvement
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 Introduction

Purpose of Quality Management

 To assure quality,
effectiveness and efficiency .
 To fulfill requirements.
 To satisfy customer
and other stake-holders.
 To be able to compete.
 To maintain sustainability WR07
  QUALITY MANAGEMENT

 Quality Management System

 Process Based QMS ISO 9000:2005
 What is Quality Management?
 Why Quality Management?
 Purpose of Quality Management

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 Introduction
What is Quality Management?
 Quality Management
- Management with regard to quality.
- Coordinated activities to direct and control
an organization with regard to quality.

Coverage
- Quality Management System (QMS)
- Quality Assurance (QA)

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 Quality Management
What is Quality Management System?
 System (ISO 9000:2005)
Set of interrelated and interacting elements.
 Quality Management System (QMS)
System with regard to Quality Management
System (QMS)
Coverage
Requirement of customer and other interested parties ,
quality policy, quality objectives, processes,
resources, and organization structure.
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 Process Based QMS ISO 9000: 2005
CONTINUAL IMPROVEMENT
OF THE QMS

CUSTOMER
Management (and other
Responsibility interested
parties)
Measurement,
Resource SATISFACTION
CUSTOMER Analysis,
Management
(and other Improvement
interested
Product
parties) Realization
INPUT OUTPUT
REQUIREMENTS PROCESSES PRODUCT
5M
Value-adding activities
Information flow WR10
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 Quality Assurance
What is Quality Assurance?
 Part of Quality Management focused on providing
confidence that quality requirements will be fulfilled
(ISO 9000:2005)
 The totality of systematic actions necessary to ensure
adequate confidence that the quality requirements
will be fulfilled.

Principles
• To build quality into the product.
• Do what was written and write what is done
• Make quality people before making quality product
• The next process is our customer
• The 5 NOs : Don’t make, deliver, accept, keep or use
Note: QAproduct.
defect is a system approach on preventing defects
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Quality Assurance
 Part of Quality Management focused on providing confidence
that quality requirements will 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 defects

 Quality Assurance
Part of Quality Management focused on providing confidence
that quality requirements will be fulfilled (ISO 9000:2005)
 The totality of systematic actions necessary to ensure adequate
confidence that the quality requirements will be fulfilled.
Principles
• Do it right from the first time and every time.
•Do what was written and write what is done
•Make quality people before making quality product
•To build quality into the product.
•The next process is our customer
• The 5 NOs : Don’t make, deliver, accept, keep or use
defect product.
Note: QA is a system approach on preventing defects
 Quality Management
The 8 principles of Quality Management
• Customer focus
• Mutually beneficial supplier relationships
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Factual approach to decision making
• Continual improvement

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 Quality Management
How to Apply Quality Management?
 Practice The Principles of Quality Management
 Practice Management Functions (POAC or PDCA)
- Clear goal statement (SMART)
Plan - Activities for goal achievement
- Resources related to activities
DCA - Do what was written and write what is done.
- IPC ( In Process Control)
- Take action for any discrepancies.

 Practice Management Review

- CAPA WR13
 Good Manufacturing Practice

 Quality Management in CPOB

 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 WR10
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
Thank You

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