2 MANTU SLIDE KULIAH 2020 Modul-2 REV

QUALITY MANAGEMENT
GMP FOR PHARMACEUTICAL PRODUCT (CPOB)
Modul-2
QUALITY MANAGEMENT SYSTEM
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2020
Modul-2
1. QMS – WHAT, WHY, HOW?

2. Organization Structure
3. Processes
4. Procedures
5. Resourcess
6. QMS ISO 9001:2015
7. ICH Q10 PQS
WR01
Modul-2
WHAT?
 QMS (Quality Management System)
System with regard to Quality Management.
> Elements: Organization Structure, Process, Procedure,
and Resources
 Quality Management
Management with regard to quality
> Implemented in any organization
> Basic elements: QMS and QA
WR01
Modul-2
WHAT?
 Management
Coordinated activities to direct and control an organization
(ISO 9000)
> The definition implies the management functions POAC.
> Management also means all those concern in managing
an organization.
 Quality
Ability to fulfil requirements.
> Ability of anything concerned.
> Requirements of anybody concerned.
WR01
Modul-2
WHAT?
 Quality
Other definitions of quality:
> Degree to which a set of inherent characteristics fulfil
requirements (ISO 9000).
> Conformity to standard or specifications.
> A relative judgment on good or bad.
# Quality is not only belong to product but it is the ability of

whatever we see, we hear, and we feel to fulfil our requirements.
# Everybody want to be happy, they want their requirement be
fulfilled, so they will be happy because of receiving good quality.
WR01
Modul-2
WHY?
 Without QMS an organization is not exist.
 To improve customer satisfaction.
 To improve organization effectiveness and efficiency.
 To improve compliance to standards and regulations.
 To improve organizational culture.
 To improve documentation system.
 Eligible QMS will assure continuous quality
improvement of an organization for its sustainability.
WR01
Modul-2
HOW?
To establish an eligible QMS:
 Define quality objectives and quality policy
 Define quality processes and resources
 Develop documentation system
 Commit to follow the related regulations.
 Launch the QMS
 Review the QMS performance
 Assess and register for certification
 Continual quality improvement
WR01
Modul-2
Modul-2
2. ORGANIZATION STRUCTURE
2. ORGANIZATION STRUCTURE
Chart illustrating hierarchical structure of function and chain of responsibility,
command, reporting, coordination and communication between superior and
subordinate level of the organization.
.
Model A Model B
Plant Plant
Manager Manager
Production Quality PPIC Technical QA

Manager Manager Manager Manager Manager
QA QC PPIC Production QC Technical

Manager Manager Manager Manager Manager Manager
# Vertical line = Commanding line # Horizontal line = Coordination line

WR08
Modul-2
3. PROCESS
Definition
Process is a connected series of actions or steps taken using
resources (5M) to transform input (requirements) into output (result).
P D
INPUT PROCESS OUTPUT OUTCOME
5M
Requirements Result Impact
A C C
Feedback > Evaluation > CAPA > Improvement

# Good process > effective & efficient # Outcome = impact = customer (stakeholders) response, profit or loss.
WR10
Modul-2
4. PROCEDURE
Procedure
 Procedure is the method or a series of actions conducted in a
certain order or manner. For example: method of analysis; master
processing procedure, etc.
 Procedure (SOP) must be validated
 Procedure may be change to fulfill new regulation or if the more
effective and efficient one has been developed, validated and
approved.
 Don’t approve unvalidated method, and don’t use unapproved
procedure.
 Continual quality improvement of procedure or method should be
carried out to increase productivity.
WR10
Modul-2
5. RESOURCES
Resources
 Resources are what we need to run the process according to its
SOP which are known as 5M, i.e, Man, Method, Material, Machine,
and Money.
 Adequate resources must be provided.
 Resources must be qualified and the method must be validated.
 Resources may be change to fulfill new regulation or if the more
effective and efficient one is available.
 Don’t approve unqualified or unvalidated resources, and don’t use
unapproved resources.
 Continual quality improvement should be carried out for more
effective and efficient resources.
WR11
Modul-2
6. QMS ISO 9001
C. Processes
12. Qualification and Validation
a. Principle
b. Planning
c. Documentation
d. Qualification
e. Process Validation
f. Cleaning Validation
g. Change Control
h. Revalidation
i. Analytical Method Validation.
WR10
WR13
Modul-2
7. ICH Q10 PHARMACEUTICAL QUALITY SYSTEM
Modul-2
7. ICH Q10 PHARMACEUTICAL QUALITY SYSTEM
Why ICH Q10 PQS?
• Different quality requirements among regionalcountries

prolong product registration process
• Higher state of control is required on pharmaceuticals
for human use.
• Product Development is not covered in GMP
• Continual improvement is not facilitated in GMP system.
•
# ICH (International Conference on Harmonization): A tripartite (USA, EU,Japan)

guidelines on effective QMS for Pharmaceutical Industry.
ASSIGNMENT
1. Compare the Quality System in Pharmaceutical Industry according
to ICH Q10 vs CPOB regulation of National Food and Drug Control
Agency?
2. Describe the purpose of the concept of Quality System in
Pharmaceutical Industry (ICH Q10) issued by ICH?
3. Describe the definition of Quality Management System including
its elements.
4. What does it mean by Organization Chart? Give one example the
Organization Chart of a Pharmaceutical Plant.
5. Describe The Basic Principles and The Technical Principles of
GMP of Pharmaceutical Products (CPOB).
THANK YOU
WR-16-QM

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QUALITY MANAGEMENT

GMP FOR PHARMACEUTICAL PRODUCT (CPOB)

1. QMS – WHAT, WHY, HOW?

# Quality is not only belong to product but it is the ability of

Production Quality PPIC Technical QA

QA QC PPIC Production QC Technical

# Vertical line = Commanding line # Horizontal line = Coordination line

Feedback > Evaluation > CAPA > Improvement

Why ICH Q10 PQS?

• Different quality requirements among regionalcountries

# ICH (International Conference on Harmonization): A tripartite (USA, EU,Japan)

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