QUALITY MANAGEMENT

Pharmaceutical Quality System

Wayan Redja
2015

QUALITY MANAGEMENT
Introduction
Quality Management
Good Manufacturing Practices in
Pharmacy
Good Trade and Distribution
Practice
Good Storage Practice
Good Pharmacy Practice

WR01

Introduction

What is Quality?
What is Quality Management?
Why Quality Management?
How to Apply Quality Management?
Scope
Purpose of Quality Management
WR02

 Introduction
A
U
Q

Y
T
LI

What is Quality?

QUALITY
Effective, Efficient > Productive
Effectiveness, Efficiency > Productivity

Effectiveness

Productivity =

Efficiency

Process Quality = Productivity

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 Introduction
A
U
Q

Y
T
LI

What is Quality?
Ability to fulfill requirements
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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 QUALITY
MANAGEMENT
What is Quality Managemen

ty
i
l
a
nt Management (ISO 9000:2005)
u
e
Q
em
g
Coordinated activities to direct
a
n
Ma
and control
an organization.

Quality Management
Management with regard to
quality.
Coverage
- Quality Management System
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- Quality Assurance

 QUALITY
MANAGEMENT
ity What is Quality Management System

al
nt
u
e
Q
System (ISO 9000:2005)
em
g
a
m
n
e
a
t
M
s
Set of interrelated and interacting
Sy
elements.

Quality Management System

(QMS)
System with regard to Quality
Management
System (QMS)

Coverage of QMS
Organization Structure,

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QUALITY MANAGEMENT SYSTEM ISO 9000

The Process Based QMS
CONTINUAL IMPROVEMENT
OF THE QMS

Management
Responsibility
Measurement,
Resource
Analysis,
Management
Improvement
Product
Realization

CUSTOMER
(and other
interested
parties)
REQUIREMEN
TS

INPUT

Value-adding activities
Information flow

PROCESSES
5M

PRODU
CT

OUTPUT

CUSTOMER
(and other
interested
parties)
SATISFACTION

 QUALITY
MANAGEMENT
What is Quality Assurans
ty
i
l
a
Qu rance
su
s
A

Note:
QA is
a
preventive
system
approach
on defects

The totality of systematic actions

necessary
to ensure adequate confidence
that a
product (or service) will satisfy
given
Basic
Principle:
Do it right
requirement
s for quality.

from the first time ,and

every time.
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 QUALITY
MANAGEMENT

Principles of Quality Assurans

Make quality people before making quality

product.
Build quality into the product.
Do it right from the first time.
Do what was written and write what is
done.
The 5 NOs : Dont make, deliver , accept,
keep and
WR04a
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use defect product.

 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
Purpose of Quality Manageme

To
To
To
To

fulfill customer requirements

assure effectiveness and efficiency
assure quality
eliminate reprocesses

To satisfy customer and other stake-holders

To be able to compete
To maintain sustainability
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QUALITY MANAGEMENT

How to Apply Quality Managemen

Practice The 8th Principles of Quality Management
Practice Management Principles (POAC or PDCA)

Plan

- Clear goal statement (SMART)

- Activities for goal achievement
- Resources related to activities

- Do what was written and write what

Do, Check, Actis done.
- IPC ( In Process Control)
- Take action for any discrepancies.
Practice Management Review
- CAPA

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What must we do before POAC or PDCA?

Do it right from the first time
State a clear goal using SMART principle. Good planning starts from
a clear goal

UNCLEAR GOAL
1. To build a
pharmaceutical
factory
next year

CLEAR GOAL
To build a pharmaceutical factory for
tablet, capacity 5 million tablet per
day, start 10 January 2017, finish 10
December 2017.

2. To compress one
To compress the intermediate
batch
product of one batch of Tablet X 500
of tablet
mg, andthen
be finished
before lunch
Plan product
realization activities,
the appropriate
resources.
tomorrow.
tomorrow..
Do the plan as planned (Do what was written, and write what is done)
Check the plan realization from the beginning until finish (IPC)
Action is taken for any discrepancies.
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 QUALITY
th
The 8MANAGEMENT
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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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

Pharmaceuti
cal
Technology
Developmen
Transfer
t Investigational
Product

Management

Commercial
Manufacturi
ng

Product
Discontinuat
ion

GM
P
Responsibilities

Process Performance & Product Quality Monitoring

System
PQS
CA/PA System, Change Management
System,
Elements
Management Review

Enablers
*

Knowledge Management
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!!!