QUALITY MANAGEMENT

IN GMP FOR PHARMACEUTICAL PRODUCT (CPOB)

Modul-1
INTRODUCTION
Wayan Redja
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2020
 QUALITY MANAGEMENT
IN GMP FOR PHARMACEUTICAL PRODUCTS (CPOB)

MODUL-1 INTRODUCTION
MODUL-2 QUALITY MANAGEMENT SYSTEM
MODUL-3 QUALITY ASSURANCE
MODUL-4 CPOB RESOURCES
MODUL-5 CPOB PROCESSES
MODUL-6 CRITICAL SUPPORTING FACILITIES
ANNEX

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 MODUL-1
INTRODUCTION

1. CPOB - WHAT, WHY AND HOW?

2. BENEFIT OF CPOB
3. THE PRINCIPLES OF CPOB / QA
4. THE PRINCIPLES OF DOING RIGHT FROM
THE FIRST TIME
5. 5R - THE GOOD HOUSEKEEPING PRACTICE
6. ERROR CLASSIFICATION IN CPOB
7. COVERAGE OF CPOB

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 1. CPOB - WHAT, WHY AND HOW?
 WHAT?
GMP (CPOB) = Good Manufacturing Practice for Pharmaceutical Products.

Definition
GMP is regulation issued by BPOM on CPOB as part
of QA which ensure that products are consistently
produced and controlled to the quality standards
appropriate to their intended use and as required by
the marketing authorization.

# Quality standards = specified quality = specification

# GMP vs CPOB
CPOB is GMP but GMP is not oly CPOB: GMP for Pharmaceutical Products
(CPOB); GMP for Active Pharmaceutical Ingredients ( CPBBOB); GMP for Traditional
Medicine (CPOTB); GMP for Cosmetic (CPKB), etc
# BPOM (Food & Drug Control Agency).
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 1. CPOB - WHAT, WHY AND HOW?
 WHY?

Why GMP must be implemented?

- To assure product quality
- Substandard medicine may risk life
- CPOB is government regulation.
- Punishment
- Bad image > bankrupt

 HOW?
How to implement GMP?
- Follow the regulations and the principles of
CPOB / QA
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 2. BENEFIT OF CPOB

 Assured QES medicines are available.

 Prevention of substandard or counterfeit medicines.
 Improvement of drug safety.
 Improvement of health care.
 Decreased of morbidity and mortality.

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 3. THE PRINCIPLES OF CPOB / QA

Before the Process (Mind set >

Management Principles).

> Build quality into the product!

> Do it right from the first time and every time!
> Provision of qualified resources (Spec) and
validated procedures (SOP)!
> Practice 5R - The Good Housekeeping Practice
> Follow the PDCA cycle consistently!
> Write what will be done (Spec & SOP)!

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 3. THE PRINCIPLES CPOB / QA

 During the Process (Actions)

> Wash hand before and after work, and after using toilet!
> Use appropriate protective clothes!
> Activities shall be made in an air controlled room
whenever the air contact with the materials or products.
> START > Line clearance > Qualified resources are used;
> PROCESS > Only validated procedures are used > Do
what is written (SOP), > Write what is done (Record/Report)! ;
> QC RESULTS > Only materials or products that conforming the
specification are released

 After the Process (Evaluation)

> Performance review > Productivity > CAPA and Continual Quality
Improvement.

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 4. THE PRNCIPLES OF
DOING RIGHT FROM THE FIRST TIME

Follow the PDCA cycle consistently!

Plan must be right from the first time > the goal
(SMART), activities, and then resources must be right.

What does it mean by right?

1. What your passion is, BUT it must be in accordance with:
2. Religion principles,
3. Regulations,
4. Science and technology principles ( effective).
5. Economic / business principles (efficient)

.
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 PDCA
Do It Right fromThe First Time and Every Time!

PDCA CYCLE ( Shewart / Deming Cycle)

Quality Management Method by iterating 4-steps (Plan, Do, Check, Act) on
each management or technical process activities to do it right from the first
time and every time for QA and CQI.

Plan : Determine Objective >

Activities > Resources
.

Do
P
: Follow SOP of the process
D Check: IPC > Analysis >
Evaluation
Act : Follow up the best

A C
solution for bad result, or
better recommendation
for good result (CQI).
QA = Quality Assurance
CQI = Continual Quality Improvement
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 TOTAL PDCA CYCLE
Total Quality Assurance

PDCA

VISION

PDCA PDCA
GOALS

OBJECTIVES
PDCA PDCA PDCA PDCA
TARGETS

PDCA PDCA PDCA PDCA PDCA PDCA PDCA PDCA PDCA PDCA PDCA PDCA
PDCA
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 PDCA CYCLE Plan > Do > Check > Act
P D Do It Right fromThe First Time and Every Time!
C A
t pu t
ou
T
CE SS ACsion
PR O Dec
i

CK ?
CHE Do >
Pl an> s N
t • s ult ct
in pu DO P R e je Y
Re
• SO rds
L AN co ase
P l • Re C OI
Re
le
a
• Go lan o r
P A PA
t ion > C ER
• Ac ack M
• 5M
e db O I CU STO
F e or C
APA
> C
c ome
t
Ou
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 5. 5R - THE GOOD HOUSEKEEPING PRACTICE
5R Realization
1. Ringkas Uncrowd
2. Rapi Neat Daily

3. Resik Clean Sustain

4. Rawat Maintain Periodically
5. Rajin Routine

■ 5R is a good housekeeping practice concept to maintain a

comfortable work station in order to increase productivity
(effectiveness / efficiency).

■ It is the foundation of the basic principle of Quality Management,

i.e “Do it right from the first time, and every time!”

■ Principle
“Keep the good in its assigned place, and keep the place with its
assigned good!”.
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 6. ERROS CLASSIFICATION

Classification of Errors
on Violation of CPOB
1. Cross Contamination
2. Degradation of Product Quality
3. Mix-up
4. Other Errors
5. Health Hazard

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 7. COVERAGE OF CPOB

A. Quality Management C. Processes

1. Quality System 6. Qualification and
in Pharmaceutical Validation
Industry 7. Production
8. Quality Control
9. Self Inspection,
B. Resources 10. Out sourcing Activities
2. Personnel 11. Handling of Product
3. Premises and Complaint and Product
Facilities Recall
4. Equipment 12. Good Storage and
5. DocumentatioN Distribution Practice
Annex: 13 Topics

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 ASSIGMENT
1. What is the definition of GMP? Is GMP similar to CPOB?
2. Why pharmaceutical industry must fulfil CPOB requirements?
3. What kind errors that may occur if CPOB requirement is not
fulfilled? Give one example for each error.
4. Define what does a process mean? Illustrate by a diagram to
explain your definition.
5.. Principle of quality assurance
a. Is the basic principle of CPOB similar tos the basic principle
of quality management or quality assurance?
b. Why the principle must be followed whenever you do any
process.
c. How to conduct the process effectively and efficiently.
6.. PDCA Cycle
a. What is PDCA cyle?
b. Explain Your answer using ISO 9001:2015 diagram
c. What is ISO 9001 : 2015? Compare in a table, ISO 9001 vs
GMP concept.
THANK YOU