QUALITY MANAGEMENT

Pharmaceutical Quality System

Wayan Redja
2016

QUALITY MANAGEMENT
INTRODUCTION
QUALITY MANAGEMENT
GOOD MANUFACTURING
PRACTICES
GOOD TRADE AND DISTRIBUTION
PACTICES
GOOD PHARMACY PACTICE
WR01

 INTRODUCTION

What is Quality?
What is Management?
What is Quality Management?
Why Quality Management?
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 Productivity = Process

Quality

WR03

 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

WR03

 Introduction

What is Management
Management

(ISO 9000:2005)

Coordinated activities to direct and control an

organization.
Note: Management may refers to people at managerial level,
e.g.
top, middle or lower management.

WR03

 Introduction

What is Quality Managemen

ty
i
l
a
nt
u
e
Quality Management
Q
m
e
ag
n
- Management with regard to
Ma
quality.
- Coordinated activities to direct
and control
an organization with regard to
quality.

Coverage
- Quality Management System WR03
(QMS)

 Introduction

Why Quality Management System

QMS can assist an organization in enhancing customer
satisfaction.
Customer requirements are changing
Competitive pressure
Advances in technology
Customer requirements should be analyzed, the
process should be defined and kept under control.
QMS provides the framework for continual
improvement
QMS provides confidence to the organization and its
Customers that its product will consistently fulfill
requirements.
WR05

 Introduction

Purpose of Quality Manageme

To assure quality
To eliminate reprocesses
To assure effectiveness and efficiency
To fulfill requirements
To satisfy customer and other stakeholders
To be able to compete
To maintain sustainability
WR08

 QUALITY MANAGEMENT

What is Quality Management?

What is Quality Management System?
Process Based QMS ISO 9000:2005
What is Quality Assurance?
The Principles of Quality Management?
How to Implement Quality
Management?
WR02

 Introduction

What is Quality Managemen

ty
i
l
a
nt
u
e
Quality Management
Q
m
e
ag
n
- Management with regard to
Ma
quality.
- Coordinated activities to direct
and control
an organization with regard to
quality.

Coverage
- Quality Management System WR03
(QMS)

 Quality Management

What is Quality Management System

y
t
i
al
nt
u
e
Q
System (ISO 9000:2005)
em
g
n a te m
a
Set of interrelated and interacting
M
s
Sy
elements.
Quality Management System (QMS)
System with regard to Quality
Management
System (QMS)
Coverage
Quality objectives, Processes, Procedures
WR03
& other
Resources, and Organization Structure.

Process Based QMS

O 9000 Family of Standards (ISO 9000, ISO 9001, ISO 9004, ISO 1901
CONTINUAL IMPROVEMENT
OF THE QMS

CUSTOMER
(and other
interested
parties)

Management
Responsibility
CUSTOMER
(and other
interested
parties)
REQUIREMEN
TS

Resource
Management

Measurement,
Analysis,
Improvement

Product
Realization
INPUT

Value-adding activities
Information flow

PROCESSES

PRODU OUTPUT
CT

SATISFACTION

 Quality Management

What is Quality Assuranc

ty
Part of Quality Management focused on
i
l
e
a
c
u
n
providing
Q ra
su
confidence that quality requirements will be
s
A
fulfilled

(ISO 9000:2005)

Basic
Principle:
Do it right
from the first
time

The totality of systematic actions necessary

to ensure
Padequate
rinciples confidence that the product will
To the
buildgiven
quality into the product.
satisfy
Do what was written and write what is done
requirements for quality.

Make quality people before making quality

product
The next process is our customer
The 5 NOs : Dont make, deliver, accept, keep or
use

 Quality Management

The principles of ISO

9000 Family

Customer focus
(ISO 9000, ISO 9001,
Leadership
ISO 9004, 19011)
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

HOW to Practice Quality Manageme

Do
it

Practice The Principles of Quality Management

Practice Management Functions (POAC or PDCA)

right

GOAL

from
the
first

P (Planning)
O
(Organizing)
A (Actuating)
C
(Controlling)

time.

Clear goal statement

(SMART) Activities

P (PLAN)

D (DO)
realization
C (CHECK)
Control)
Management Review
A (ACTION)

Resources
Product
IPC ( In Process
CAPA

Good Manufacturing Practice

for Pharmaceutical Product (CPOB)

Pharmaceutical Quality System: ICH Q10 PQS

What is GMP for Pharmaceutical Product (CPOB)
Errors in Implementation of CPOB
Why CPOB?
Purpose of CPOB
Critical Supporting Facilities in CPOB
How to Implement CPOB Principles
Product Realization in CPOB
Documentation
Quality Audit and Annual Product Review
Management Review and Continual Improvement

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 Pharmaceutical Quality
System
What is ICH10 Pharmaceutical Quality Sys
S
PQ
Pharmaceutical Quality System
(ICH Q10)
- A model for an effective QMS for the
pharmaceutical industry.
- The model design is based on QMS ISO 9000, ICH
Q7 ( GMP
for API), ICH Q8 (Pharmaceutical Development),
ICH Q9
An ICH harmonized tripartite guideline from the
(Quality
RiskConference
Management)
as the complement
International
on Harmonization
of
Technical
Requirements for Registration of
of GMP
for
Pharmaceutical for
Human Use.
Pharmaceutical
Product.

ICH Q10 PQS

International Conference on Harmonisation of Technical Requirements for

Registration of Pharmaceuticals for Human Use (USA, EU, Japan)

Pharmaceuti
cal
Technology
Developmen
Transfer
t Investigational
Product

Management

Commercial
Manufacturi
ng

Product
Discontinuat
ion

GM
P
Responsibilities

Process Performance & Product Quality Monitoring

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

Enablers
*

Knowledge Management
ty
Quality Risk Management

ICH Q10 PQS

Purpose

Achieve product realization

Establish and maintain a state of
control
- Monitoring system of process performance
and product
quality throughout the product life cycle

Facilitate continual improvement

- Audit
- APR

- Management review
- CA / PA system

Good Manufacturing Practice

for Pharmaceutical Product (CPOB)

12 Aspects of CPOB
Quality Management
Resources
1.
2.
3.
4.

Personnel
Premises
Equipment
Documentation

Processes
5.
6.
7.
8.

9. Handling of Product Complaint, Product

Sanitation and Hygiene
Recall, and Returned Product
Production
10. Contract Manufacture and Analysis
Quality Control
11. Qualification and Validation
Self Inspection and
Quality Audits

Product realization in GMP for

Pharmaceutical Product

WR10

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

WR12

Good Pharmacy Practice

Scope
What is GPP
Why GPP
Purpose of 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!!!