Indonesia’s Pharma Serialization and Traceability Requirements

Studies on Indonesia’s pharma serialization and traceability requirements continue at full speed, as it is in all countries that prioritize human health. The regulator of Indonesia’s pharmaceutical serialization practices is the Indonesian Food and Drug Authority (BPOM – Badan Pengawas Obat dan Makanan).

Indonesia’s Pharma Pharmaceutical traceability practices started via QR code technology in 2018 and then GS1 Data Matrix was included. Indonesia’s pharma serialization and traceability requirements differ according to product groups. Adopting GS1 standards in 2D Code implementation, the Indonesian Food and Drug Authority (BPOM) requires serialization and aggregation within the scope of traceability requirements.

Timeline for and Indonesia’s Pharma Serialization Traceability Requirements

Serialization requirements result in regulations in the production lines. Likewise, some systemic changes are required for aggregation operations. Since this is a process itself, BPOM has provided a timeline to manufacturers to meet Indonesia’s pharmaceutical serialization and traceability requirements.

BPOM asked for feedback from the pharmaceutical industry before submitting the timeline in 2018. Therewith, some companies have reported that they would be ready for serialization by implementing GS1 2D code as of 2019. The decision afterwards was that the QR code and GS1 DataMatrix could be applied.

The report on barcode implementation, serialization and reporting standards was announced in 2019. According to the regulations published, the Indonesian pharmaceutical industry has to comply with the traceability requirements according to the timeline starting from 2020 and continuing until 2027.

Events Affected the Identification of Indonesia’s Pharma Serialization and Traceability Requirements:

• In 2018, the first steps for traceability with QR codes have been taken.
• In 2019, industry stakeholders declared that they are ready for serialization with the implementation of GS1 2D code.
• In 2020, With the released regulation, BPOM made aggregation and SSCC implementation obligatory.

Timeline:

A schedule was set to meet pharmaceutical Indonesia’s pharma serialization and traceability requirements. The deadlines varied according to the size and type of pharmaceutical company hereunder:

• For large-scale manufacturers and wholesalers: January 1, 2021
• For medium-scale manufacturers and wholesalers: July 1, 2021
• For small-scale manufacturers and wholesalers: January 1, 2022

However, BPOM later published the Revised Tracking and Monitoring Regulation on the Implementation of 2D Barcodes in Pharmaceutical and Food Traceability No. 22/2022, which will enter into force on October 5, 2022.

Change in the dates has saved time for industry stakeholders and has created an advantage for them to make the right choice among suppliers that produce traceability technologies. Official authority BPOM also carries out studies to inform industry stakeholders in this process.

Barcode Requirements in Indonesia’s Pharma Traceability

All medicines sold in Indonesia must have a unique 2D code that meets GS1 standards. This code applied to the primary packaging must contain the following information:

• GTIN or MA number
• Marketing authorisation number
• Batch number or production code
• Serial number
• Expiration date

Experienced Company, Efficient Solutions

VISIOTT has created systems for companies in various countries with the experience it has and became a preferred supplier owing to its wide service network. Standing out with its innovative hardware and software and wide service network, VISIOTT presents solutions that fully conform to the Indonesia’s pharma serialization and traceability requirements.

Durable Systems for Indonesia’s Pharma Serialization

The solutions developed by VISIOTT TPS for the Indonesia’s pharmaceutical industry are completely tailor-made and consider product specifications and packaging structure. ISS-100 Carton Serialization Station used for Indonesia’s Pharma serialization stands out with its high speed and ergonomic design.

Also bearing companies using unfolded boxes in mind, VISIOTT TPS has developed a practical solution for the pharmaceutical industry with the FCSS-100 Flat Carton Serialization Station. Developed by VISIOTT TPS for vials preferred in packaging vaccines, serums and injectable products, VBL-300 Vial Labelling and Serialization Station performs labelling and serialization at high speed. Allowing the serialization of products of different sizes with its star wheel shape, the VBL-300 presents superior engineering and design. LSP-100 Label Serialization Station With Puncher can print all the information requested in line with the code and legal requirements on the label and provides convenience to manufacturers by producing ready-to-apply labels. Combining 2D code implementation and product security, ISSTE-200 Carton Serialization with Tamper Evident Labelling provides an organized solution by serializing products and implementing a security label.

Achieving a Systematic Success Through Aggregation

A successful traceability system can be achieved through integrated serialization and aggregation processes. Being aware of this, BPOM required pharmaceutical manufacturers to implement aggregation. VISIOTT TPS-designed aggregation stations for production processes are easy-to-integrate solutions for the Indonesian supply chain.

MAS-100 Horizontal Manual Aggregation Station, a rare solution for pharmaceutical manufacturers, resolves even low-quality QR codes with a high success rate thanks to its special image system. MAS-200 Vertical Manual Aggregation Station, which has the same success rate, is produced for practical and fast data processing. Produced for companies that package their products manually, SMAS-100 Semi-Automatic Aggregation Station performs the aggregation process using the data of serialized products in multiple layers. SACP-100 Semi-Automatic Case Packer with Aggregation, designed by expert engineers, combines product packing and aggregation process. SACP-100 places the packaged products that are put into the system by the operator and the aggregation process is carried out.