GOOD DISTRIBUTION PRACTICES FOR MEDICAL DEVICES

CARA DISTRIBUSI ALAT KESEHATAN YANG BAIK (CDAKB)

&
GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICE
CARA PEMBUATAN ALAT KESEHATAN YANG BAIK (CPAKB)

Presented by :
Drs. Taufik Sugianto, MKM

Directorate of Post Market Control of Medical Devices and Household Product

Directorate General of Pharmaceuticals and Medical Devices
Ministry of Health of Republic of Indonesia
 Minister of Health Regulation No. 4-2014
Good Distribution Practice Medical Devices

Ensure the quality, safety and performance of medical device during all
aspects of medical device supply-chain, which include, but not limited to,
product sourcing and procurement; transportation and delivery; storage;
installation, commissioning, service and maintenance, calibration and aft
er sales service; tracking, documentation and
record-keeping practices.
Minister of Health Regulation No. 20 - 2017
Good Manufacturing Practices of Medical
Devices (CPAKB)

Mandatory
Good Manufacturing
Practice Medical Device

All Medical device industry must

implement Good Manufacturing
practice CPAKB within 4 years at
the latest
 CDAKB & CPAKB BENEFITS
• Implementing a Quality Management System, in
general, helps to motivate staff and provide a
better definition of roles and key responsibilities.
• Reduce operational costs by highlighting process
deficiencies and improving efficiency
• Increase customer satisfaction by consistently
delivering quality products and systematically
addressing complaints
• Proven commitment to quality through an
internationally recognized standard
• Adds transparency to the way complaints,
surveillance or product recalls are handled
Who?

Foreign manufacturer Local authorized repres

Distributor
entative /Distributor
ISO 13485
CDAKB

Local manufacturer Distributor

CPAKB CDAKB

Where?

office Manufacturer Warehouse

 HOW ?

The organization shall establish, document, implement and maintain a QMS

(quality management system) and maintain its effectiveness in accordance t
o the requirement of Minister of Health Regulation No. 4-2014 CDAKB /GD
PMD (Good Distribution Practice for Medical Devices ) and/or Minister of He
alth regulation No. 20 – 2017 CPAKB (Good Manufacturing Practice for Medi
cal Device)

Where an organization choose to outsource any activities that may affect the
quality of medical devices, the organization shall ensure control over such
processes.
 HOW ?
1. Prepare:
1. Interpret clauses in GDPMD(CDAKB) or CPAKB
2. Mapping process internally
3. Say what you will do  create documents (SOP, WI)
4. Do what you have said  execute and maintain what is docum
ented
2. Get audit internal minimum 1 time in 1 year
3. Get Review Manajemen minimum 1 time in 1 year
 How?

Establish & document = documentation

Example: Standard Operation Procedure (SOP), Work Instruction (WI).

Implement & Maintain = record

Example: training record, distribution record.

Ensure control over such process =

• Responsibility segregation
• SOPs / WIs & record
• Verification / audit
 FLOW OF AUDIT CPAKB/CDAKB PROCESS

MANUFACTURE/DISTRIBUTOR

Submit a Letter of Application for CPAKB/CDAKB Audit to the

Director of the Directorae Postmarket Control of Medical
device and house hold product

The Director of the Directorate Postmarket

Control of Medical device and house hold Non comformity
product appointed the CPAKB/CDAKB Audit
Team

Audit Team CPAKB/CDAKB doing

preparation

Audit teamCPAKB/CDAKB conduct an

audit in the field CDAKB : 2-3 day
CPAKB : 3-4 day

Auditee doing CAPA

Non (Corrective Action
Result of audit? comformity Preventive Action)

CPAKB ; Fee PNBP: Rp. 5.000.000,-

Comply
CDAKB ; Fee PNBP: Rp. 3.000.000,-
Certificate CPAKB/CDAKB comply
 COMPARING ISO 9001 AND ISO 13485 /CPAKB

While iso 13495 is based on iso 9001, there are some key differences and
Additional requirementts, in addition to product-spesific demands
And more stringent documentatiton requirement

Plus
KEY ADDITIONAL OF ISO 13485:
ISO 9001 -Risk management required at all stages of product realization
-Training and supervison of staff
-Multiple d ocumentation requirements
-Monitoring whether customer requirements are met, rather than
more subjective customer satisfaction measures
-Maintaining the continued suitability and effectiveness of the qualitity
management system, rather than striving for continuous improvement
 CLAUSE ON MOH No.20/2017
CPAKB

• Quality Management System

• Management Responsibility
• Resource Management
• Product Realization
• Measurement, Analysis and Improvement
• Regulation
 COMPARING ISO 9001 AND GDPMD /CDAKB

For organisations that had been certified to GDPMD/CDAKB

ISO 9001 QMS , various requirement of
GDPMD/CDAKB are covered under ISO 9001.
ISO 9001
The ISO 9001 is not equivalent to
GDPMD/CDAKB .
 Clause on MOH No. 4/2014 CDAKB

QMS Storage and ha

Buildings and
HRD ndling supplies Traceability Customer co
Facilities mplaint

1 2 3 5 6
4

pemu
snaha
n

Ilegal and doesnot

Audit Manajemen Third party
CAPA Return Disposal
meet the standard Internal review activities

7 8 10 11 12
9
13
Training Program for CPAKB and CDAKB Capacity build
ing

2107 : CPAKB : Jakarta, has done on Mei 2017

Surabaya, Next oktober 2017
CDAKB : Jakarta, has done on Mei 2017

2018 : CPAKB : 3 time in 1 year

CDAKB : 1 time in 1 year
 Certification Audit Results

Certification ≤ 2015 2016 2017

CPAKB 17 11 9
CDAKB 3 8 5

CPPKRTB 1 12 5

Total 21 31 19

23 process on audit
THANK YOU