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)

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

Presented by : Drs. Taufik Sugianto, MKM

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)

All Medical device industry must

implement Good Manufacturing

practice CPAKB within 4 years at

the latest

Mandatory

Good Manufacturing

Practice Medical Device

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?

Local manufacturer

Foreign manufacturer Local authorized repres

entative /Distributor

Distributor

Distributor

Where?

office Warehouse

CPAKB

CDAKB

CDAKB

Manufacturer

ISO 13485

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

MANUFACTURE/DISTRIBUTOR

Non comformity

Non comformity Result of audit?

Comply

Certificate CPAKB/CDAKB comply

Auditee doing CAPA (Corrective Action Preventive Action)

Audit teamCPAKB/CDAKB conduct an

audit in the field

Audit Team CPAKB/CDAKB doing preparation

The Director of the Directorate Postmarket Control of Medical device and house hold

product appointed the CPAKB/CDAKB Audit Team

Submit a Letter of Application for CPAKB/CDAKB Audit to the Director of the Directorae Postmarket Control of Medical

device and house hold product

FLOW OF AUDIT CPAKB/CDAKB PROCESS

CPAKB ; Fee PNBP: Rp. 5.000.000,-

CDAKB ; Fee PNBP: Rp. 3.000.000,-

CDAKB : 2-3 day CPAKB : 3-4 day

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

ISO 9001 KEY ADDITIONAL OF ISO 13485: -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

Plus

• Quality Management System

• Management Responsibility

• Resource Management

• Product Realization

• Measurement, Analysis and Improvement

• Regulation

CLAUSE ON MOH No.20/2017

CPAKB

COMPARING ISO 9001 AND GDPMD /CDAKB

For organisations that had been certified to ISO 9001 QMS , various requirement of GDPMD/CDAKB are covered under ISO 9001. The ISO 9001 is not equivalent to GDPMD/CDAKB .

GDPMD/CDAKB

ISO 9001

Third party

activities

1 2 5 6 3 4

pemu snaha

n

Ilegal and doesnot

meet the standard

11 7 8 10 12 9 13

CAPA

Return

Disposal

Audit

Internal Manajemen

review

QMS

HRD

Buildings and Facilities

Storage and handling supplies

Traceability

Customer complaint

Clause on MOH No. 4/2014 CDAKB

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

Training Program for CPAKB and CDAKB Capacity build

ing

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