2D BARCODE “SERIALIZATION”

IMPLEMENTATION STRATEGY

Hendry Candra Dewanto

Workshop IAI Kab.Bogor

Bigland Hotel, Sentul
4th of Nov 2023
TABLE CONTENT
1 Background

2 Strategy
 Background

• On Dec. 7th, 2018 Indonesia FDA (BPOM) has announced the

rule of 2D Bar Code Requirements on the Drug, Food and
Cosmetic Packaging.

• BPOM aims to improve drug and food control effectively,

before and during circulation through IT System which is 2D
Bar Code.

• Implementation of 2D Barcode regulation require big effort

and investment. Therefore, preparation step is critical.

3
 2D BARCODE
The BPOM Regulation No.33 Year 2018 dated 7 December 2018.

Identification
OTC, Food, Cosmetic
Method to verify legality product based
on its License. The 2D Barcode contain
License number and its Validity period.
The same 2D barcode for all of batches
for each item.
Authentication
Ethical Drug
Method to trace and track the legality of
drug product. The 2D Barcode contain
License number, batch number, expiry date
and serial number of product. Each single
package, each 2D Barcode
 2D BARCODE
The BPOM Regulation No.33 Year 2018 dated 7 December 2018.

Identification
OTC, Food, Cosmetic
Method to verify legality product based
on its License. The 2D Barcode contain
License number and its Validity period.
The same 2D barcode for all of batches
for each item.
Authentication
Ethical Drug
Method to trace and track the legality, batch
number, expiry date and serial number of
product. The 2D Barcode contain License
number, batch number, expiry date and serial
number of product. Each single package, each
2D Barcode

✓ Need CAPEX
No Need CAPEX ✓ SERIALIZATION
PROJECT
 Serialization: Physical and Data
Assets
• Each batch will now effectively have 2 sets of assets, the physical i.e.
packs of cartons and the data i.e. electronic reports
• One without the other can’t be distributed.

CMO/Global
site

Scan-in

Warehouse

Packaging
Line

6
 STRATEGY

1 Team
2 Vendor Selection
3 Process & Milestone
4 Cost Structure
5 Alternative Solution

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 1 PROJECTTEAM

Task:
• Minimum 1. Regulation assessment
Resources PerKa BPOM against
company impact
• Product
(packaging design, SOP,
Development
Process, etc)
• Manufacturing 2. Gain Knowledge 2D
• Quality SERIALIZATION Barcode implementation in
• Technical & other company
Maintenance 3. Project Management
• Regulatory 4. Bussiness Process review
5. Generate User
• Procurement
Requirement Specification
(URS)
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. Vendor Selection
2

Check and performed

assessment in several
Challenge aspect:
• Provide solution by
follow company
procedures, business
process and meet URS
• Reputable company
• No compliance issue
• Amount of CAPEX
and/or annual OPEX
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 3 PROCESS &
– Feasibility study
MILESTONE
– Packaging Design
– Vendor Selection
– Pack. Development Phase 1 Phase 3
Implementation Implementation

1st Year 3rd Year On Going

2nd Year 4th Year

– Investment Phase 2
– Machine Qualification Implementation
– Submission for pack. site
transferred
 4 COST STRUCTURE

• CAPEX
✓ Serialization Unit & System

• OPEX
✓ Development Cost for Primary Packaging
✓ Training Cost
✓ Registration cost
✓ Annual system cost (if any)
✓ Consumable part (ink, belt, etc)

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5 ALTERNATIVE SOLUTION

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Thank you!