Implementation of GMP (CPAKB) and

Challenge for Entering Global Market

Jakarta, July 27th , 2017

PT Panasonic Healthcare Indonesia (PHCI)

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 Implementation of GMP (CPAKB) and
Challenge for Entering Global Market
Contents:

1. Introduction of Panasonic Healthcare Indonesia & Products

2. CPAKB and Several Good Manufacturing Practices (GMPs)
3. CPAKB vs ISO13485:2016
4. Key Points of Medical Device Manufacturing
5. Set Up Proper Quality Management System (QMS)
6. Implementation of CPAKB & Obstacles
7. Challenges to Develop Indonesian Medical Devices
8. Strategy for Entering Global Market
9. CE Marking and Approval Process

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 Implementation of GMP (CPAKB) and
Challenge for Entering Global Market

1 Introduction of Panasonic Healthcare Indonesia & Products

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Company Profile Introduction of Panasonic Healthcare Indonesia and Products

Panasonic Healthcare Corporate Overview

Headquarters : 2-38-5 Nishi Shimbashi, Minato-ku, Tokyo, Japan
Business Area : Development, manufacture and sale of healthcare devices and services
(In vitro diagnostic devices, medical IT solutions, life science devices and services, etc.)

Ascensia Diabetes Care Holdings AG

Headquarters : 2-38-5 Nishi Shimbashi, Minato-ku, Tokyo, Japan
Head Office : 2131-1 Minamigata, Toon, Ehime 791-0395, Japan
(Previously Bayer Diabetes Care Holding AG)
Business Activities : Development and Distribution of Diabetes Care Products and Service
Incorporation : November 21, 1969 (Established in November, 1948)
Headquarters : Basel, Swizerland
Sales Revenue : US$1.4 billion
Sales Revenue : US$ 1.3 billion

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Company Profile Introduction of Panasonic Healthcare Indonesia and Products

Panasonic Healthcare Solutions

Utilization of Medical Information Link Diagnosis and Treatment Suppoting Drug R&D
(Medical IT Solution) (In Vitro Diagnosis Devices) (Laboratory & Medical Support Devices)
In Operation Room Ward Examination Room/ Radiology Dept.
Medical Imaging
Ultraosund Diagnostic
System

Diode Lazer System for

Catering System Photo Dyanamic
3D Monitor 2D Monitor Medical Recorder Theraphy (PDT)
Oculmotor Function
Testing Equipment
Preservation
In Hospital Pharmacy
Picture Archiving &
Medication Automation Communication
System (PACT)

Incubation
Medication Picking Auto Tablet Counting Tablet Inspection
System & Dispensing System System

Medical IT Examination Room

Self-Monitoring of
Blood Glucose System
Picture Archiving & Experiment
Patient Record Medical Receipt Blood Glucose
System System
Communication System System
(PACTS) Monitoring System for
Hospital
Clinic / Medical Primary Care Community Care Hospital
Computer based
Point of Center Testing University/ Research Facility
(POCT)
Medication History
System FeNO
(Fractional enhanced
Nitric Oxide) Measuring
Devices
Cell Theraphy
Field

Dental Clinic

Bactery Dental Intraoral Dental Materials/

Cell Processing Center
Counter Camera Waser Desinfector
Dental Prosthesis (CPC)

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Company Profile Introduction of Panasonic Healthcare Indonesia and Products

Panasonic Healthcare Indonesia Product Overview

Link Diagnosis and Treatment Suppoting Drug R&D Utilization of Medical Information
(In Vitro Diagnosis Devices) (Laboratory & Medical Support Devices) (Medical IT Solution)

In Vitro Diagnostic Division Biomedical Division Medical Information System Division

Self-Monitoring System
for Blood Glucose
Bio Medical Medicom
Blood Glucose Monitoring Incubators
Sensor Medical Refrigerator

Electronic Health Record Medical Receipt System

Lancet
Blood Glucose
Monitoring System
-Personal Healthcare
Medical Prescription -Health Insurance Billing System
Blood Monitoring System Equipment Medical Freezer PACS

Small Blood Monitoring System

(POC)
Global Manufacturing Center
Cell Therapy Dental & Oral Care
Blood Glucose Monitoring Medical Imaging
System for Hospital

Electronic Injector
Human Growth Hormone
Dental Intraoral
Bacteria
Medical Monitor
Camera Counter
Parkinson’s Disease
Therapy
PHC Indonesia Production: = Finished Goods = SKD

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Company Profile Introduction of Panasonic Healthcare Indonesia and Products

Panasonic Healthcare Indonesia Production History

Business Transformation

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Company Profile Introduction of Panasonic Healthcare Indonesia and Products

Company Outline
 Name PT Panasonic Healthcare Indonesia
 Address Kawasan Industri MM 2100, Blok O-1, Cikarang Barat,
Bekasi 17520, Indonesia

 Established May 20, 1991

 Company History 1991 : Established as PT Kotobuki Electronics Indonesia (KEI)

1998 : Name changed to PT Matsushita Kotobuki Electronics
Indonesia (MKI)
2005 : Name changed to PT Panasonic Shikoku Electronics
Indonesia (PSECI)
2011 : Name changed to PT Panasonic Healthcare Indonesia (PHCI)
 Capital US$ 29.69 MIL.
95% Panasonic Healthcare Co.,Ltd.
5% PT Gobel International
 Employees 657 persons (4 Japanese), < June End 2017>

 President Director Hirano Tsuguru

 Area Building: 60,000 m2 Land: 108,790 m2

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Company Profile Introduction of Panasonic Healthcare Indonesia and Products

International Standard Organization Certificates

ISO13485:2012 ISO9001:2015 ISOTS16949:2009

ISO14001:2004 OHSAS18001:2007

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Company Profile Introduction of Panasonic Healthcare Indonesia and Products

National or Regional Regulations Certificates/Registered

Certified Certified Certified E.U. Certified Certified
Establishment CPAKB (GMP) Medical Directory Product Safety Factory

Indonesian MoH EU MDD U.S. and Canada Japan MHLW

Registered
Certified Certified Compliance
Establishment & Factory
Product Safety Certified
Device

US FDA China CQC Korea FDA Canada QPS

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 Implementation of GMP (CPAKB) and
Challenge for Entering Global Market

2 CPAKB and Several Good Manufacturing Practices (GMPs)

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 CPAKB and Several Good Manufacturing Practices (GMPs)

CPAKB (Indonesian GMP)

 What is GMP (Good Manufacturing Practice)
A GMP is a system for ensuring that products are consistently produced and controlled according to
quality standards. It is designed to minimize the risks involved in any pharmaceutical production
that cannot be eliminated through testing the final product.

Main Items of GMP Guidance for CPAKB

 Apa itu CPAKB ( Cara Pembuatan Alat Kesehatan yang Baik)

CPAKB adalah sistem untuk menjamin bahwa produk alat kesehatan dibuat dengan konsisten
dan dikontrol sesuai dengan standar mutu.
Sistem ini dibuat untuk meminimalisasi risiko termasuk yang timbul pada produksi alat kesehatan
dan perbekalan rumah tangga yang tidak bisa dieliminasi melalui pengujian produk akhir.

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 CPAKB and Several Good Manufacturing Practices (GMPs)

CPAKB and Other GMPs

Country Regulator Regulation/ Std. Inspection Period
(Insp./ Re-certification)

Ministry of Health Pedoman MoH

(Kemenkes) every 1 year/ 5 years
Indonesia (MoH) / Kemenkes CPAKB,
Revisi 2016

Code of Federal
USA US FDA Regulation (CFR) US FDA every 4 years/ NS
Part 21, 2015

MHLW every 2 years/ 5 years

JQA Japan
Japan Japan MHLW Ministrial Ordinance
No.136, 2004

CNCA-C08-01
China CQC CCIC every 1 years/ 4 years
:2014

MSDF
Korea Korea FDA Law 11690 Korea FDA every 2 years/ 3 years
2013

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 3 CPAKB vs ISO13485:2016
Items CPAKB Clauses ISO 13484:2016 Clauses Comparison

1. 2.1. Ruang Lingkup 1. Scope Same

2. 2.2. SISTEM MANAJEMEN MUTU 4. Quality Management System Same

3. 2.2.1. Persyaratan Umum 4.1. General Requirements Same

4. 2.2.2. Dokumen dan Pengendalian 4.2. Documentation Requirements Same

5. 2.2.3. Tanggung Jawab Manajemen 5. Management Responsibility Same

6. 2.2.4. Pengelolaan Sumber Daya 6. Resource Management Same

7. 2.2.5. Realisasi Produk 7. Product Realization Same

8. 2.2.6. Pengukuran, Analisa dan 8. Measurement, Analysis and Same

Peningkatan improvementt

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 Implementation of GMP (CPAKB) and
Challenge for Entering Global Market

4 Key Points of Medical Device Manufacturing

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 Key Points for Medical Devices Manufacturing

KEY POINTS:
1. Top Management Commitment
(Regulation compliance, Safety, Quality, Customer)
2. Construct Proper Quality Management System (QMS)
3. Environment Control
(Cleanlines, Sanitation, Temperature & Humidity, Lighting, ESD, Pest)
4. Risk Management
5. Product Traceability (Product and Material, Process, Equipment, Person)
6. Customer and Quality First (Quick action for quality)
7. Changes Control (4M: Material, Man, Method, Machine)
8. Validation (Process & Product)
9. Patrol System (make sure everyone follow the rule)
10. Good Vigillance Practice (GVP)
(Active monitoring market, Reporting Adverse event )

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 Key Points for Medical Devices Manufacturing

1.Top Management Commitment

VISION

MISION

VALUES

Commitment and Policy to be 1st Priority:

• Human Life (User Risk)
• Regulation Compliance
• Product Safety (Effectiveness)
• Product Quality

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 Key Points for Medical Devices Manufacturing
2. Construct Proper Quality Management System (QMS)

QMS ISO13485 Concept  Combine All Requirements

Japan
USA  Simplify system
Indonesia Japan PAL & MHLW  Procedures = Actual Operation
No.121, 2005 & No. 169, 2004 FDA QSR
RI MoH
Regulation QMS for MD 21 CFR Part 820
(No.1189/MENKES/ EN ISO13485:2012/AC:2012
Get All Required Certifications
PER/VIII/2010) Korea
ISO
China CCC QMS KFDA a. Management Certifications
ISO9001:2008
MDD
(MDD/93/42/EEC)
IVDD 98/79/EC ASEAN MRA

EU ASEAN Countries
b. Product & GMP Certification
Good Manufacturing Practices (GMP)
CPAKB

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 Key Points for Medical Devices Manufacturing
3. Environment Control (Cleanlines and Sanitation)
Implement One Way Entrance  Protect Product and Employee from
Contamination:
Employee Entrance Particle, Chemical, Bacterial, Pest
 Get all employee follow the rule

Use Production Hand Washing ESD

Uniform and Antiseptic Confirmation
Enter Production Change Shoes
Area Outdoor  Indoor

Video Visualization Work Direction at Changing room

Indirect/ Guest Entrance

ONE WAY ENTRANCE:
 Pest Controled Entrance
(No gap, Pest Trap &
 Particel Protection Entrance
(Double lock door, Air shower )
 Chemical Protection Entrance
(Hand & Shoe wash, Antiseptic, Strerile Uniform)
 ESD Protection Entrance
(ESD Measurement, Anti ESD Uniform)

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 Key Points for Medical Devices Manufacturing

3. Environment Control (Temperature, Humidity, Air Circulation, Light)

a. T & RH Measurement Layout:
Ref. Doc.: WIMD-RM-PE-03

 Observe Object of Protection:

a. Products  Product Spec.
b. Process  Process Requirement
c. Human  Employee Health Regulation

Control: Temperature and Humidity:

1. Office = T: 23+5⁰C, RH: <60%
2. Production = T: 23+5⁰C, RH: <60%
3. Warehouse = T: 25+5⁰C, RH: <75%
b. Humidity & Temp. Measurement Equipment with Data Recorder 4. Special Process = as spec.
Light:
1. Office & Production: 300-500 Lux
2. Special Process: as spec
c. Air Conditioner  Provive Specific T & RH
 Circulate to Outside Flow
 Consider Object of Protection when using:
- Wall or Roof Opening
d. Air De-Humidifier  Provide Low Humidity Environment - Exhaust or Air Blower

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 Key Points for Medical Devices Manufacturing

3. Environment Control (Electro Static Discharge - ESD)

1. Provide ESD Measurement Layout:

Observe Object of Protection:

a. Products  Product Spec.
b. Process  Process Requirement
c. Human  Employee Health Regulation

Control ESD Level:

1. Critical Part & Process : <50 V
2. Ground : 0-10 Ohm
3. Employee Protection: R :1 MOhm

2. Provide ESD Protection:

(Antistatic Shoes, Uniform, Discharge Chain, ESD Mat)

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 Key Points for Medical Devices Manufacturing

3. Environment Control (Pest Control)

Ref. Doc.: WIMD-RM-HRD-03
Factory 1 Pest Trap type
Total Trap 168 traps
(Factory 1: 108 Factory 3: 60)
Floor Trap : Factory 1 : 66
Bait Roden for Trap for Insects
building outside on the floor Factory 3 : 44
PVC Trap : Factory 1 : 7
Factory 3 : 3
HangingTrap for Bait Roden for Black Box : Factory 1 : 9
flying insects building outside floor
Factory 3 : 6
Hanging Trap : Factory 1 : 16
Sodium Lamp to
Chase away the Insect
Factory 3 : 3
Sodium lamp : Factory 1 : 10
Factory 3 : 4

Classification
Ring 1(Production, OGI) Ring 3(Outside + Office)
Monitoring and Prevention Activity:
Ring 2(IQC,Change Room)
Close coordinate with ETOS (Sub-Contractor to tight control and
Factory 3 monitoring with below concrete action: (example)
1. Periodic spraying insecticide
2. Periodic checking un-controlled access to healthcare area
3. Improve drain system of toilet healthcare
4. Place additional trap (out side of Ring 3)
5. Reporting to management monthly

Protect Product & Human from

Pest Contamination
 Critical Area: Ring 1 = Zero Pest

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 Key Points for Medical Devices Manufacturing

4. Risk Management  Implement ISO14791: Risk Management

RISK MANAGEMENT COMMITEE

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 Key Points for Medical Devices Manufacturing

4. Risk Management Tool Implement Process FMEA

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 Key Points for Medical Devices Manufacturing

5. Product Traceability (Product & Material, Process, Equipment, Person)

Supplier Integrated Traceability Utilization System Customer

MC WH
I TRUST

IQC OGI

SMD FINAL ASS’Y

KITTING

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 Key Points for Medical Devices Manufacturing

6. Customer and Quality Fast Action (Scramble meeting & 1 stop action)
Quick Action for Quality Trouble
At Central Office: At Production Line:
Fast Warning (Alarm/Buzzer) system One Stop Action

Problem
Indicator Button Panel
& Buzzer

Put the NG unit on the NG area

for alarming

Prompt Action & Judgment

Shipment Stop
& Release Alarm On

Line Stop
& Re-Start

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 Key Points for Medical Devices Manufacturing

7. Changes Control (4M: Material, Man, Method, Machine)

External Internal
Approval Approval 4M Change Form & History
4M Variance Standard Change
( Process + Supplier )

4M Change Request

Variance Analysis
(4M Variance Standard)

Factory Engineering
Evaluation

Human (Man) Qualification System

Approval
Change Visualization Control
( Internal/ External )
Production layout and
4M Change Form operator’s mapping

4M Change
Issued

Today 4M
Change

Implementation
MATERIAL MACHINE MAN MAN

4M Change
Sample

Ref. Doc.: OSMD-PP-08

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 Key Points for Medical Devices Manufacturing

8. Validation (Process & Product)

Validation Implementation Team
Validation Master Plan Start PHCI
Validation
phase Dept PE Dept QA Dept FE Dept Produksi
IQ ◎ O O O
OQ O O ◎ O
Validation Plan
PQ O ◎ O O

CTQJ (Critical to Quality Judgment)

Process Validation – IQ/
Validation Implementation Plan
Installation Qualification (OQ)
Validation Report (OQ)

Process Validation – OQ/

Operational Qualification
Validation Implementation Plan (PQ)

Validation Report (PQ)

Process Validation – PQ/
Performance Qualification

Final Approval Validation Report

Validation Summary List
QA & Responsible Engineer

End/ Report

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 Key Points for Medical Devices Manufacturing

9. Patrol System  Make sure everyone follow the rules

 Conduct Safety & QC Patrol
Product Safety Patrol
 Check compliance with safety process rules.  Dummy Test for Operator & Inspector
 The patrols check whether safety process
operations are conducted according to process
control charts and operation instructions and by  Ensuring that the relevant personnel are fully
authorized personnel. aware of check points.
Safety Inspector caps
(red)  Improve awareness due to changes.

QC Patrol
 The patrols check whether all process
operations are conducted according to process
control charts and operation instructions and
Product Safety
Safety Processes by authorized personnel.
Patrol sign

SMD Final Assy Safety Inspector caps (orange)

Assy Acoustic Charger Acceso- Packing
SMT AOI Kitting
Unit Check Cradle ries Label

Dummy Test Defective Parts for Inserting to unit or mixed-up

Schedule Dummy Test with OK parts

QC Patrol sign
Operator as object of Record Common Processes
Dummy Test

 Wrong part
 No mark CAN
 Polarity reversed DETECT?

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 Key Points for Medical Devices Manufacturer
10. Good Vigillance Practice (GVP)  Active monitoring market
 Report adverse event/ accident

Internal PHC Domain Report Public and MoH Report

• Report to PHC BU • Report from User/Public

• Report from Maker/

Company
• Report to Regulatory Government

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 5 Set Up Proper Quality Management System
 QMS/GMP Certification is Trade Barrier or Business Opprtunity?
QMS ISO13485 Concept  Combine All Requirements
Japan
USA  Simplify system
Indonesia Japan PAL & MHLW
No.121, 2005 & No. 169, 2004 FDA QSR  Procedures = Actual Operation
RI MoH
Regulation QMS for MD 21 CFR Part 820
(No.1189/MENKES/ EN ISO13485:2012/AC:2012
Get all Certifications = Gate of Trade
PER/VIII/2010) Korea
ISO
China CCC QMS KFDA a. Management Certifications
ISO9001:2008
MDD
(MDD/93/42/EEC)
IVDD 98/79/EC ASEAN MRA

EU ASEAN Countries
b. Product & GMP Certification
Good Manufacturing Practices (GMP) / CPAKB CPAKB

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 Implementation of GMP (CPAKB) and
Challenge for Entering Global Market

6 Implementation of CPAKB and Obstacles

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 Implementation of CPAKB and Obstacles

Overall Process Quality Plan

First Process (PCB Ass’y)

• Normal OGI

Material Control W/H

Finished Goods W/H

First Process (SMD)
• Safety OGI

Final Assembly
• Reliability Test

Customer
Supplier

IQC OGI SRE

WIMD- WIMD- WIMD-PQA-Dept Prod-01 WIMD- WIMD- WIMD-PP-

PCP-QA- PCP- PQA-QA- PQA-QA- MCL-03,
01 MCL-01 02 02 WIMD-PP-
MCL-04,
WIMD-PP-
MCL-05

Incoming inspection
In-process inspection
Final process inspection

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 Implementation of CPAKB and Obstacles
 Clear Identiification
Material and Part Receiving  Clear Segregation
 Proprer Storage (T, RH, ESD)

Receiving of parts

Check invoice with

INPUT P/NO. & ISSUE GR
actual & box condition
UN-LOADING RECEIVING AREA
AREA

FIFO LABEL, RoHS & SAFETY IDENTIFICATION Register P/No. for Good
GOOD RECEIPT SLIP (GR)
Affixed FIFO Receipt (GR) issue
Label on each Central PK
packing box Display

Confirm Part category

Part Store Identification of
PK at Material Receiving from GR Slip safety parts & QI
Status
(need IQC or not):
S, U, V, E, M =
Affixed Label and stored Safety Part;
R = RoHS Rank A
in a specific Area I = Important Part
Part No. /
Part Name

Incoming
PASS
GATE TO Inspection
IQC
Ref. Doc.: WIMD-PCP-MCL-01, WIMD-PCP-MCL-02

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 Implementation of CPAKB and Obstacles
 Clear Segregation (OK, NG)
Incoming Inspection (QC)  Justified Acceptance Criteria
 DHR: Traceable Record
PASS
GATE IQC ACTIVITIES
FROM
Receiving Safety Check
MC

BEFORE INSPECTION Safety & Important :

Yellow line circling area to

Receive parts & Good * Visual Check
* Measurement
located parts before IQC Transfer Slip (GTS) Non Safety Check * Reliability
(Store by Product
Category)

Incoming Inspection
GTS for part category
Safety Important = I RoHS = R
RoHS Check
U,V,E,M

Sampling plan Approval Samples as

ANSI ASQC Z1.4
AQL 0.1 reference for Incoming
Inspections RoHS Checksheet
RoHS Inspection Criteria
AFTER INSPECTION
Part Unit Dip.Solder

Blue-line circling area to

located the parts after IQC
(Store by Product Store parts after
Category)
Incoming Inspection

Overall red- Overall

line area to orange-line
located the area to located Kept for one year
NG safety the NG non-
MC Warehouse
SAMPLE PART
part. safety part.

Ref. Doc.: WIMD-PCP-QA-01

Handling Nonconforming Procedure: WIMD-PCP-QA-02
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 Implementation of CPAKB and Obstacles
 Clean, Comfort,Pest Free Area
First Process (SMD) Production  Proper Process & Inspection
 Traceable DHR

Incoming Inspection

Safety Part Area

Rack List MC Warehouse

SMD Process
• Special Part

Auto Optical Inspection

(IPK + Marantz)

PCB Assy
Confirmation Line
Doc.: WIMD-PP-SMD-01
WIMD-PP-SMD-02
WIMD-PQA-SMD-01

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 Implementation of CPAKB and Obstacles
 Clean, Comfort, Pest Free Area
Second Process (PCB Assy)  Proper Process & Inspection
 Traceable DHR
PRODUCTION SUB-STORE
• Electrical Part
Incoming Inspection
PCB ASSY PROCESS

FIFO method
displayed simply on
MC Warehouse
site
Raw part store area
(Photo Part and Part No.)

SMD Process

Working
Instruction

PCB Assy Process PASS/ FAIL CHECK

PASS/ FAIL CHECK

Packing Process

Doc.: WIMD-PP-PCBA-01
WIMD-PP-PCBA-02
WIMD-PQA-PCBA-01 Final LCD Monitor

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 Implementation of CPAKB and Obstacles
 Clean, Comfort, Pest Free Area
Final Assembly (GMS) Production  Proper Process & Inspection
PRODUCTION SUB-STORE
 Traceable DHR
PCB assy store area
FINAL ASSY PROCESS
Incoming Inspection

MC Warehouse
Packaging store area
Unit Level

SMD Process Working

Instruction

Raw part store area FIFO method

displayed simply on site
PASS/ FAIL CHECK

Final Assy

Packing Process

S/N Record Unit

Level Ref. Doc.: WIMD-PP-FGMS-01, WIMD-PP-FGMS-02,
Outgoing Inspection WIMD-PQA-FGMS-01

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 Implementation of CPAKB and Obstacles
 Clean, Comfort, Pest Free Area
Final Assembly (LCDM) Production  Proper Process & Inspection
 Tracable DHR
PRODUCTION SUB-STORAGE

Incoming Inspection
Assembly

Identification area for MC Warehouse

part storage

SMD/PCB
Assy Process Final
inspection
FIFO method displayed
Rack
simply on site
identification

Final Assy
Safety test
(WI test,
leakage
current)

Packing Process

Ref. Doc.: WIMD-PP-FLCDM-01, WIMD-PP-FLCDM-02,

Packing WIMD-PQA-FLCDM-01
Outgoing Inspection

39
 Implementation of CPAKB and Obstacles
 Clean, Comfort, Pest Free Area
Final Assembly (DIC) Production  Proper Process & Inspection
 Tracable DHR
PRODUCTION SUB-STORAGE

Incoming Inspection Assembly

Identification area for MC Warehouse

part storage

SMD/PCB
Assy Process Final
inspection
FIFO method displayed
Rack
simply on site
identification

Final Assy
Safety test
(WI test,
leakage
current)

Packing Process

Packing Outgoing Inspection

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 Implementation of CPAKB and Obstacles
 Clean, Comfort, Pest Free Area
Out Going Inspection (QA)  Justified Pass Criteria
 Traceble DHR
 Clear Segregation & Identification
OGI Inspection Area

Production
Sampling plan ANSI ASQC Z1.4 Level II

Taking Sampling Product

1. Aging 2.WB

Outgoing Inspection
100% Sampling

3. Function 4. Withstanding for PR,PP & 1st Lot MP

AFTER OGI Lot Status Report for 2nd Lot MP

onward

SRE Approval
SRE Approval

LOT STATUS F/G Warehouse

REPORT issued
goods to enter
F/G warehouse Doc.: WIMD-PQA-QA-02
Handling Nonconforming Procedure:
• WIMD-PQA-QA-04
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 Implementation of CPAKB and Osbtacles
 Clean, Comfort, Pest Free Area
Final Biomedical Assembly  Proper Process & Inspection
 Tracable DHR
Material Control Warehouse
Incoming Inspection
Assembly

Identification area for

part storage
MC Warehouse

Kitting Trolley
identification
FIFO method displayed
simply on site
Appearance
Inspection

Final Assy
Safety test
(WI test,
leakage
current)
Packing Process

Ref. Doc.: WIMD-PP-FDIC-01, WIMD-PP-FDIC-02,

Packing Outgoing Inspection WIMD-PQA-FDIC-01

42
 Implementation of CPAKB and Obstacles
 Clean, Comfort, Pest Free Area
Finished Good Ware House  Clear Segregation & Identification
 Traceable DHR (Barcoding)
Production Final

APPROVAL DOCUMENT
Check Lot Status Approval & Lot Status Shipping Approval
box condition
HOLD AREA

Divide by
product
category Classify product and storage
on each area

S/N Shipped Control Shipping Instruction received

Receive Shipping Instruction

* S/N recorded
Record Serial number/
Barcode

Container Loading
Doc.: WIMD-PP-MCL-03

43
 Implementation of CPAKB and Obstacles

Pictures of Factory

Entrance of Production Area SMD (Surface Mount Devices) Production Area

44
 Implementation of CPAKB and Obstacles

Pictures of Factory

Glucose Meter Final Assembly Production Finished Good Warehouse (IVD)

Biomedical Final Assembly Production Finished Good Warehouse (Biomedical)

45
 Implementation of CPAKB and Obstacles

Pictures of Factory

On Going DHR Area DHR Room

Water Lever Alarm (Out side) Gas Fire Protection Electronics DHR

Device History Record (DHR) Area

46
 Implementation of CPAKB and Obstacles

Obstacles during Implementation of CPAKB

1. Employee Know how and Mind Set of medical device.

2. Insufficient management experties of medical devices

manufacturing.

3. Insufficient information of overseas GMPs and applied

regulation especially for export purposes.

4. Difficulties to combine all regulations in one quality

manual and procedures.

47
 Implementation of GMP (CPAKB) and
Challenge for Entering Global Market

7 Challences to Develop Indonesian Medical Devices

48
 Challences to Develop Indonesian Medical Devices

A. Provision of Accredited Testing Laboratory (Clinical & Safety)

 Lack of Indonesian Accredited Testing Laboratoty

Distribution
Indonesia Clinical & Safety Indonesian

Lisence of

(Ijin Edar)
Test Market

Distribution
Testing
Laboratory
? ?
Free Sales Certificate

Certificate of
Exportation
? ?

(CE)
 Human resource
 Testing capability
 Accreditation

Distribution
?

Lisence of

(Ijin Edar)
Clinical & Safety
Test Overseas
Overseas
Testing Market
(include

Distribution
Laboratory
ASEAN)
Free Sales Certificate

Certificate of
Exportation
49
(CE)
 Challences to Develop Indonesian Medical Devices

B. Provision of Local Material and Components (Upstream Industry)

 Lack of Local Material & Components

Local Local
Finished Good Maker Finished Good Maker

Local Local
Ass’y Maker (tier 1) Ass’y Maker (tier 1) Less Availability of Local
Material & Components
Local Maker (Upstream Industry)
Local
Componets Maker (tier
Componet Maker (tier 2)
2)

Local Local Ovrseas X Local Ovrseas X Ovrseas X

Material Maker Material Maker Material Maker Material Maker Material Maker Material Maker Need reinforcing for
Local Upstream
Manufactures

50
 Challences to Develop Indonesian Medical Devices

C. Provision of Applied & Economical R & D Results

 Most of the R& D Result only until Prototyping

Demands Research & Developments Prototyping or Users
Testing Purposes

Testing, Certification, Sales and Distribution

Hospital Patient
University Mass Production
Opportunities

R&D Center
? Doctor & Assistants
Risk/ Incident

Requirements Corporate R&D Personal Home

Care

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 8 Strategy for Entering Global Market
 Synergized Actions of all Stake Holders:

Government/ 1. Promote to establish Clinical & Safety Testing Labs.

Regulator: 2. Provide Regulation and Harmonized Standards
3. Promote for Bilaterlal & Multilateral Agreements
4. Provide Guidance and Education
5. Surveilance and Law Enforcement
6. Policy to enhance upstream local manufacturer

Manufacturer: 1. Build Quality Global Excellent Manufacturing

2. Enhance Corporate black box and know how

1. Provide Applied & Economical R&D results

University:
2. Support for standards establishment

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 8 CE Marking and Approval Process

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 CE Marking and Approval Process
QUALITY SYSTEM BY CE CLASS

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 Panasonic Healthcare Indonesia

Thank You

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