Track & Trace solutions for the pharmaceutical products which are traded between numerous stakeholders and have direct effect on human health has become a necessity. These products are exposed to many different processes and risks in their journey from the manufacturer to the final consumer which could affect the substance of the product. Traceability of the product lowers this risk of manipulation when it is applied according to the regulations by the manufacturer companies. Track and trace solutions enables the product to be tracable in every step of the manufacturing and transfers for different kinds of sectors but the pharmaceutical sector in priority.
Global Serialization Overview
The first purpose of the track and trace systems is to provide patient safety. The collected data is used to detect the violations which threats the patient safety. These violations are recorded and processed to serve for the precautions and preventive actions to provide secure environment in the distribution of the pharmaceutical products. This is the fundamental outcome of the track and trace systems: building trust between the patient and the medication.
Nowadays, track and trace projects are being carried out in different places on earth. Numerous countries are taking steps in order to construct their own track and trace system for the pharmaceutical products. Turkey’s Ministry of Health’s “The Pharmaceutical Track & Trace System” in Turkey is the first track and trace project in the world for pharmaceutical industry and become the leading role model for many countries. Please enjoy our little library below which is about the track and trace projects over the world. Do not hesitate to contact with us anytime for more information.
The Drug Supply Chain Security Act (DSCSA) has came into force with the joint action of Food and Drug Administration (FDA) in the United States market. With this act, the companies which are producing pharmaceutical products are being monitored closely, and they have to adapt themselves with the new regulations. When the serialized products are introduced to the market all stakeholders from the manufacturer to the wholesalers have to start to act accordingly with the necessities of the system. The item level product has to be marked with a 2D code which contains the product identifier, serial number, batch number and expiration date according to DSCSA requirements.
The track and trace project was projected to be started on 27 November of 2017 but this start time delayed by FDA to 26 November of 2018 because most of the companies had experienced difficulties to finish their conformity process.
The track and trace project have been published formally with the act number 13.413 at 28 December 2016. SCNM started a 3 staged process to configure and determine the rules of the act which has been discussed through 2016.
The security requirements for pesticide and pharmaceutical products are determined with the EU 2016/161 regulation and published on 2 October 2015 in the official journal. All member countries are obliged to suit with the requirements before 09 February 2019. The EU 2016/161 regulation is connected with 2001/83/EC directive. All pharmaceutical products distributed in the market have to have alphanumeric codes and anti tampering devices. The pilot experiments for the serialization operations started in 2017. Serialization is based on four fundamental elements which are the product identifier, serial number, lot number and expiration date. There is one extra fifth element available for some market, which is National Trade Item Number (NTIN). The pharmaceutical products have to be registered in European Medicines Verification System (EMVS) in order to be able to be sold in the EU market.
Indian pharmaceutical companies and CMOs have started serialization with datamatrix coding in 2011. In 2012, system’s requirements were specified and by 2015 serialization has been implemented. DAVA (Indian Drugs Authentication Portal) asks pharmaceutical companies to meet all required criterias. Serialization process consists of; product identification number, serial number, batch number and expiration date.
DAVA Imp. Guidelines: http://dava.gov.in/davanew/files/DGFT_Drug_Track_N_Trace_Implementation_Manual.pdf
DAVA registration Guidelines: http://dava.gov.in/davanew/files/Registration.pdf
Chinese Track&Trace System has begun in 2012. Firstly serialization (in 2012), and then, aggregation actions (in 2015) were started to be implemented by CFDA. On March 2017, government made serious changes on the previous regulations and they declared that new requirements would be published in accordance with the pharmaceutical qualities. On October 2017, the Ministry of Commerce reported a need for traceability standard and launched serialization standards studies according to the industry requirements by openning GS1 China traceability workshop. The pilot project was launched on October 2018 and CFDA has printed 20-digits digital electronic code.
Current Serialization Requirements:
Conveyor linear barcode 128 C
In December 2017, the law No 425-FZ according to the serialization and reporting reqiurements have been published and pharma producers were asked to manage and report in all stages-from production to the last consumption. First pilot scheme was applied in 2016 and all producers must register to the traceability agency of Russian government by January 1, 2019.
KPIS Korea Pharmaceutical Information Service began to develop serialization system on January 1, 2015. After the completion of serialization requirements in 2016, South Korea began their track and trace operations on July 1, 2017.
Serialization Requirements :
GS1 datamatrix or GTIN embeded to GS1-128 Linear barcode, serial number, lot number and expiration date
The serialization regulations are still being developed in Taiwan and are expected to be implemented in 2023. GTIN/Lot Number and expiration date were decided to be embedded to datamatrix code on January 1, 2018. According to the pilot schemes, serial number will be added to datamatrix code by January 1, 2019.
Serialization Requirements :
Standard GS1, Transfer -2D barcode datamatrix
SFDA Saudi Arabia Food and Pharmaceutical Authority mandated labelling policy in 2015 and serialization operations of all stakeholders at GS1 standards on March 12, 2017.
GTIN embedded to GS1 datamatrix, serial number, lot number ve expiration date
ANMAT, the regulatory authority, conducted a serialization meeting on March 28, 2012; however, it still have not clarified the national serialization ve reporting requirements of pharmaceuticals. Studies of similar serialization structure with China have started. Since 2013, barcode labelling format have being applied. Today’s producers are trying to adjust their barcod labels to appropriate serial number according to GS1 standards.