PHARMACEUTICAL INDUSTRIES

AT A GLANCE

BANDUNG, SEPTEMBER 2016

NI NYOMAN WIWIK SUTRISNI
 MEDICINE

PHARMACEUTICAL TECHNOLOGY

SAFETY

EFFICACY QUALITY

cGMP
 cGMP CONCEPT

Selected Robust
21st Century cGMP Material Method

Controlled Qualified
Environment Machinery

Trained
personnel
 SAFE,EFFECTIVE,HIGH QUALITY PRODUCT

INNOVATION PRODUCTIVITY QUALITY

 Managing Director

Manufacturing
Marketing Director Finance Director
Director

Quality Operational
R&D Manager Plant Manager
Manager
Quality
Formulation PPIC
Assurance
Quality
Analytical Production
Control
Engineer &
Packaging
HSE

Purchasing
 PRODUCT DEVELOPMENT
ICH Q8 :
The aim of pharmaceutical development is to design a quality
product and its manufacturing process to consistently deliver
the intended performance of the product. The information and
knowledge gained from pharmaceutical development studies
and manufacturing experience provide scientific
understanding to support the establish of design space,
spesifications, and manufacturing control.
GENERIC PRODUCT DEVELOPMENT

FORMULATION ANALYTICAL PACKAGING

DOSSIER DOCUMENTATION

Master formula Analytical Closure system

method & Spec
PPIC : PRODUCT PLANNING AND INVENTORY
CONTROL

Inventory control
raw/pack material
master list

G Raw/ pack
Finished good
D material
warehouse*
warehouse*
P

Production
Dispensing*
Planning

* Subject to premises controlled

PRODUCTION
Key issues : avoid cross contamination & mixed up risks
General line vs Dedicated line (special)
Betalaktam
Cephalosphorin
Corticosteroid
Hormon
Oncology
Biological product

Requirements
Non-sterile product
Sterile product (Annex 1): Aseptic vs Terminal
sterilization
PREMISES & UTILITIES
(CPOB 2012 : CHAPTER 3)

Room
HVAC Water system
Clasification
PIC guideline Purified water A : under LAF
AHU system RO- EDI B : Sterile room
Water for C: Sterile room
injection WFI D : Clean room
generator
E : Non-sterile
processing
room
F : Packaging
room
G : Ambient
condition
PRODUCTION FLOW
(CPOB 2012 : CHAPTER 6)

Documentation batch record

QC
Processing Sampling Packaging
Bulk (WIP)

IPC IPC

QA Released
FG
ENGINEERING

Building Utilities Production

Maintenance * Mechanical support
+ * Electrical * Periodic
Waste maintenance
management * Breakdown
(IPAL) * HSE
PURCHASING

Raw & Pack Production

support General
material
purchase

User Requirement
Approved spesification
vendor list (URS)

Monitoring & Controlled system

QUALITY CONTROL
(CPOB 2012 : CHAPTER 7)

Good Laboratory Practice & ISO 17025

SOP for sampling
Validated method & Spesification
Raw/ Pack Identification & Decision (Released vs rejected)
Material SOP for retest procedure

IPC
Bulk in Sample testing
process

Validated method
Finished Out of spesification (OOS) handling
good
QUALITY ASSURANCE
(CPOB 2012 : CHAPTER 1)

TOTAL QUALITY
MANAGEMENT SYSTEM

ICH Q8 : Product Development

ICH Q9 : Risk Management

ICH Q10 : Quality Management System

 Continous cGMP training program

Room qualification & Environment

Material, monitoring
method
Personel
Machineries qualification
Environment,
Machinery
Cleaning validation

Material manufacturer & Supplier audit

Product
Process validation

Change Control

Document controller
 QUALITY

PRODUCTIVITY

INNOVATION