FREQUENTLY ASKED QUESTIONS ABOUT PHARMACEUTICAL TRACK-AND-TRACE

In an effort to improve drug safety, many countries are implementing regulations to identify and track drugs throughout their journey to the patient. Traceability is the ability to follow the trajectory of a given drug within its supply chain through records carried out at each supply chain stage.

Traceability solutions are implemented through two processes: serialization and aggregation.  Serialization involves adding a unique serial number (code) to sellable units of the product, so that they can be identified and traced throughout the supply chain.

Items placed into a secondary/tertiary packaging (i.e. case/pallet) are then aggregated. This means another unique serial number is placed onto the secondary/tertiary packaging providing information about all the serialized items contained therein.

Once serialized and aggregated, the goods are entered into the manufacturer’s database and may be sent to a regulatory entity’s system, where the serial numbers are monitored and allow the possibility of rebuilding the distribution chain of each individual unit.

Level 1 – refers to the physical equipment (hardware) used for traceability, such as printers and cameras.

Level 2 – refers to the software that controls the serialization and aggregation hardware present in a packaging line, such as our LineMaster software, which can tell if a printed code has all the information and quality necessary to proceed or if the defective item must be rejected.

Level 3 – is considered the plant manager and is responsible for centralizing what happens in multiple production lines.

Level 4 – refers to the cloud platform that creates and distributes serial numbers, centralizes information from multiple plants and sends the necessary data to regulatory entities.

Level 5 – are the governmental bodies that monitor the pharmaceutical supply chain.

Government authorities all around the world are defining and implementing track and trace regulations with which the pharmaceutical industry must comply. To better understand the requirements for the United States, European Union, Brazil, Russia and China see our Regulation Map.

Each serialization provider has their own pricing structure.  At OPTEL, we do not charge for individual serial numbers, it’s a flat fee structure.

Adding a new process to a production line will invariably impact the time a product runs through the line. In order to make an assessment on performance, we need to take into account the chosen solution. The more automatic the solution is, the less the impact. As an average, one may expect a 5-7% impact on performance when starting the operation. As the team comes to understand the operation of the systems, this value decreases and may return to previous levels.

Not necessarily, but a connected system allows you to exchange information more quickly and accurately. For example, when connected to an ERP, a new batch can be started by simply selecting the production order number. All other information relevant to that batch will be loaded automatically.

In addition, the connection to third-party systems brings greater control of the data. Depending on the type of process, this can actually be inevitable. For example, suppose that you have a case with multiple products that need to be distributed into different cases for a specific purchase order. A new box label will be needed to complete the aggregation process for your new content. In this case, it will be necessary to have a system connected to the WMS, which generates a new serial number and stores the new aggregation data, to later send this data to governmental entities.

It all depends on the company’s objective. To comply with most legislations, it will not be necessary for you to connect to your distributors and or partners, but they will need a station that connects with the regulating entity and sends them events that have occurred.

For complete visibility of your supply chain, process optimization, fast and accurate recall, assistance in diagnosing problems, customer confidence and brand protection, we recommend connecting with your partners.

The adoption of traceability usually requires the installation of new equipment on existing lines and it is quite common for lines to be stretched. The amount of space that will be taken will depend entirely on the solution selected. In situations where there is no available physical space, a customized solution should be evaluated, such as the integration of hardware inside a cartoner.