HOW DO I IMPLEMENT DRUG TRACEABILITY?

Did you know that the pharmaceutical industry has only until April 2022 to implement drug traceability (track-and-trace) systems in Brazil? Although time for compliance is tight, there’s no need to worry: OPTEL offers the best drug traceability solutions, with the additional benefit of optimizing your supply chain. And, if you are wondering how to start your track-and-trace implementation process, check the initial steps to achieving drug traceability below.

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5 STEPS TO START A DRUG TRACEBILITY PROJECT

1.   CREATE A TRACEABILITY COMMITTEE OR GROUP

A traceability project affects several operational areas, such as engineering, IT, production, quality, regulatory affairs, etc. To guarantee successful implementation, this therefore means having supporters in every department.

Get department representatives together to create a traceability group. Start with an orientation meeting to discuss the main points in Brazilian regulation and benefit from OPTEL’s free training on Anvisa’s updates. Contact us to book your meeting. Also, take advantage of the orientation meeting to appoint a leader that will oversee the project and to be the point of contact with your traceability systems supplier.

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2. MAP OUT THE PACKAGING LINES THAT WILL REQUIRE SERIALIZATION AND AGGREGATION

Anvisa has specified through its Normative Instruction that, all prescribed (those with black or red stripes) must be part of the National Drug Control System (Sistema Nacional de Controle de Medicamentos, SNCM). Identify which of your lines will, as a result, need to be part of the traceability implementation. Note that if all your products are marketed in secondary packaging (cartons), you will not be required to serialize the primary packaging. Only the smallest unit sold unit must be serialized. Find out in more detail how pharma track-and-trace works in Brazil.

Once you have defined which lines need to be equipped with the new traceability systems, gather layout plans of the lines that show the physical space constraints on the equipment, compile the layout plans of the products and their shipping cases, and compile information about production speeds and other details on the machinery. All this information will help your supplier to better understand your needs and offer you the best solution according to your requirements.

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3.   DEFINE WHAT MUST BE ENCODED ONTO THE PRODUCTS

The Brazilian track-and-trace regulation requires: the Global Trade Item Number (GTIN); the Anvisa registration number; the serial code; expiry date; and manufacturing batch number. But let’s say you would also like to add the manufacturing date, which is not required by law but is important for your company, this must be discussed and established with the team.

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4.  INVITE SUPPLIERS TO VISIT YOUR COMPANY AND TO DESIGN A PRELIMINARY TECHNICAL AND BUSINESS PROPOSAL

The same way you offer unique products, your requirements for a traceability project are unique. Get your potential suppliers to visit you, so they can understand your structure, processes, hardware, and software. This is the moment to define operational limits (false rejects, the maximum area for encoding, etc.), get an estimated cost and assess the implementation timeline.

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5. DEVELOP THE USER REQUIREMENT SPECIFICATION (URS) AND A SUPPLIER COMPARISON WORKSHEET

This stage is fundamental to choosing the right supplier. Make the URS as detailed as possible to ensure that all the suppliers are technically equal. Come to OPTEL for help with writing the URS and get in contact to receive a supplier comparison worksheet example that contains the main assessment criteria you need before choosing your supplier.

OPTEL SOLUTIONS FOR DRUG TRACEABILITY

OPTEL is a specialist in developing and integrating traceability technologies to comply with legislation. OPTEL has a local support team to customize every project, and its cutting-edge technology enables supply chains to be optimized for further use of data.

Want to know more about OPTEL’s drug traceability solutions?

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