GMP (CPOB)

Is aimed to ensure that products is

consistenly manufactured.
Reduce risk that cant be detected with product
testing:
Cross contamination
mixed

GMP Background
Society health protection
medicine

high quality

Development of technology
developed in pharmacy

rapidly

Harmonization and globalization

standard and pharmacy regulations

in

Pharmacy industrial category based on

production facility (jan.2008)
First : production facilitated self-owned
Second : production facilitated self-owned
with continuous improvement
Third : production partly facilitated selfowned and partly facilitated by Toll
Manufacturing
Fourth : Toll Manufacturing ( certain time
period)
Grouping appropriate with all aspects and
criteria in CPOB

4 Critical Aspect on CPOB

Validation
HVAC ( air management)
Water system
Sterile product

Determinants of good quality product

High quaility product
QA/QC
VALIDATION
PERIODIC
OBSERVATION

Building
And
facilities

Starting
equipment material

Personnel
Procedure
environment

Air management
Environment factor
Directly effected to product quality :

lights

temperature

humidity

bacteria contamination

particel contamination

Water System
Water is one of critical (vital) aspects for
the implementation of c-GMP.
Water is the main component in drug
production.
In contaminated, water can be dangerous
Water treatments are intended to remove
the contaminants according to the water
quality standard

 Water Qualification
Grade 1 : Raw water
Function
Making

: fire extinguisher, watering plants, etc.

: water from well, PDAM, etc.

Grade 2 : Potable Water

Function

Making

: washing clothes, cleaning non sterile

tools, cleaning rooms, washing hands
, bathroom, etc.
:

Raw water Iron Removal Sand Filter Chlorinasi

Carbon filter Potable Water

Grade 3 : Purified Water (Aquademineralisata)

Function
Making

: container final washing, production of

syrup, tablet, coating, etc.
:

Potable Water De-ionization micro filter 3 um

Micro filter 1 um micro filter 0.2 um UV Lamp
Purified Water

Grade 4 : Water for Injection

Function

Making

Purified
water

: Sterile container final washing, vial

and ampul washing, sterile
production, and laboratory.
:

Destillation Unit

Water for
Injection