Serialization and DSCSA compliance

Several years ago, more than 500 manufacturers, distributors, and consultants came together to discuss problems in the healthcare supply chain in the United States. This meeting dealt with the issue of counterfeit medicines in the supply chain and how to reduce their number.

At this meeting, the idea of serializing products was introduced, and the need to improve traceability in the healthcare supply chain was discussed. Here’s what it all means.

 What is the serialization of products?

The serialization of products is the unique identification of products, which is brought down to the level of individual articles, rather than to the level of batches. Pharmaceutical serialization involves identifying packages of different drugs, that is, assigning them a two-dimensional code unique in the world and marking it on the box. pharmaceutical serialization services and equipment are also provided by many,

With the implementation of product serialization, an appropriate product tracking system must be integrated throughout the supply chain. This type of comprehensive system will allow US wholesalers to verify products and exchange data with other wholesalers in the supply chain.

This initiative is called DSCSA compliance, and each manufacturer, repackager, and wholesale distributor of pharmaceuticals and each pharmacy in the United States must comply with regulatory requirements.


What is DSCSA compliance?

Compliance with the DSCSA (“Drug Supply Chain Security Act”) is the American initiative to prevent the introduction and distribution of counterfeit drugs.

The main objective of this compliance is to allow manufacturers, repackaging companies, and wholesale distributors of pharmaceutical products, as well as pharmacies and third-party logistics services, to exchange information on each package of medicine and see precisely where it went in the supply chain.

This will help them verify products, identify illegal products anywhere in the supply chain, and make drug recalls more effective.


All of this is made possible by the introduction of serialization and traceability technology. All product data will be stored in a secure cloud-based repository.


How to comply with the DSCSA?

To comply with the DSCSA, each company in the pharmaceutical industry concerned by DSCSA compliance laws must enter the transaction information (TI for “Transaction Information”), the transaction. He must keep his TI, TH, and TS for each purchase for six years. He must only ship licensed products, and he can never change the transaction history in any way.

The serialization and traceability of pharmaceutical products will modernize the pharmaceutical industry. This initiative will revolutionize the sector and hopefully eliminate all counterfeit drugs from the supply chain.

If you need a reliable solution for tracking products in the healthcare supply chain, rfxcel is there for you. We can help you meet all the needs of product serialization and comply with the DSCSA standard in no time. Contact us today to find out more about how we can help you.

The industry pharmaceutical It continues its fight against counterfeiting, although some companies, such as CMOS (subcontractors) and SMEs, have not yet launched their serialization projects. Sliski has spoken with Pharma IQ about the implications of the serialization of packaging for CMOs and SMEs in the pharmaceutical and biotechnology industries. Although they should race against time to meet deadlines, Sliski says these companies still have time to put in place a complete and agile serialization infrastructure.

Apart from the printing and application systems, what do you think are the main repercussions that the serialization of pharmaceutical packaging has for CMOS?

According to various sources, more than 40% of pharmaceutical production is outsourced, making CMOS a strategic part of the entire supply chain process. However, in many cases, they have postponed the serialization of pharmaceutical packaging until the last minute or have carried it out in a fragmented way.

CMOS must comply with international regulations, but they must also be flexible to adapt to the different requirements of their clients. Unlike SMEs, CMOS typically must meet the needs of the companies they work for and the countries in which they operate. This involves making changes that go far beyond modifications to your tagging devices and infrastructure.

One of the main challenges of serialization has to do with the fact that three types of data are combined: master data, transaction data – which establish the traceability of a serialized item (part, package, box, or pallet) in the packaging process— and the physical product. Following the regulations, all these elements must be linked continuously and dynamically. To achieve this objective, it is necessary to develop specific skills.

These competencies include: physically marking the serialized code on the product – sometimes using different systems, serialization formats, and types of packaging – guaranteeing traceability and complying with regulations. To this must be added the aggregation steps, because creating relationships between the different levels and maintaining them can be a legal or standard requirement to facilitate operational efficiency as regulations are applied. Therefore, it is necessary to establish the relevant links between each phase to ensure the visibility of the physical events, the different transactions, and the corresponding master data.

Knowing this, what are the most critical steps CMOs should take to overcome these challenges during serialization deployment?

With all the levels to be taken into account interconnected, one of the main steps is to ensure that everything is correctly connected to the equipment and that the company can manage serialized data (i.e., supply, exchange, reception, dispatch, and storage).

The key is to achieve this without affecting the efficiency of the equipment. If the performance of the packaging line is reduced, this can have a very negative impact on productivity and productive capacity. Therefore, it is essential to optimize the integration between the different components of the line, which include marking, checking, validation, and weighing devices. All these checks and verifications have to be carried out in a short period. They must be linked to all transaction data and master data before being transmitted to the national repository. Managing to fit all these pieces on time, efficiently, and synchronized is a real challenge.

For those SMEs that have not yet launched their serialization projects and who will have to trust that execution works the first time, what would you advise them when facing the serialization of pharmaceutical packaging?

Regulatory compliance is the most important objective, but you must also define broader business objectives and plan the steps necessary to generate more value. For this reason, many companies are focusing on aggregation – between different levels, boxes, etc. – to facilitate the next steps and speed up the supply chain.