Pharma Serialization – The Most Comprehensive Description
Governments have developed an effective and efficient method of combating drug counterfeiting that directly affects public health in the last decade. The main goal of this method is that we can trace the drug during the supply process. The first step to implement the method is pharma serialization.
Over the past decade, many legislators have prepared laws and regulations that make pharma serialization obligatory. DSCSA in the United States, EU-FMD in the European Union, and ITS in Turkey are the most notable examples. Pharmaceutical manufacturers and other players in the industry face problems from time to time as they try to assure compliance with the requirements of these regulations. In this article series, we will try to explain every aspect of serialization in the pharmaceutical industry.
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What is Pharma Serialization?
Pharma Serialization is assigning a unique code to the packaging of each drug and printing this code on the packaging by any method. There are two main points in this definition. The first is the unique code and the second is the drug packaging.
The definition and structure of the unique code are defined within the regulations of the countries. The unique code definition within the regulations of all countries is largely similar to each other and follows GS1 standards. The areas that differ are generally the codes and cryptography preferences of the reimbursement institutions. In the following table, you can find unique code examples for countries’ pharma serialization practices.
Packaging in the pharmaceutical industry has three main headings.
Primary Packaging: Primary packaging is the packaging in contact with the drug. The aluminum blister is the most common primary packaging used in the vial and bottle industry. The serialization of the primary packaging is not a requirement in any market other than the American and Indian markets. Because only in these markets, even if it is exceptional, the patient can purchase the primary packaging.
Secondary Packaging:It is the packaging that contains the primary packaged medicine or medicines. The best example of this packaging is the carton. On average, 80% of the medicines in the world are sold in a carton. The serialization of this packaging is a must for regulations compliance. Some regulations, such as EU-FMD, require Tamper Evident, along with pharma serialization, to guarantee that the medicine is first opened by the patient.
Tertiary Packaging: You can carry out B2B operations in the supply chain by making medicines into a whole with tertiary packaging. The best examples of tertiary packaging are bundles, cases, and pallets. The serialization of tertiary packaging is the most important point to ensure traceability in the supply chain. Since the serialization and aggregation of tertiary packaging is a very detailed topic, we recommend you to read our article “The A to Z of Pharmaceutical Aggregation”.
How to Implement Pharma Serialization
Legislators usually use guidelines from the GS1 organization, which specializes in traceability, when preparing regulations on pharma serialization. Using the definitions in these guides, the structure of the data carrier 2D Datamatrix code which meets the requirements of the pharmaceutical market can be easily built compliance with local regulations. Serialization for a drug is complete when the built code is printed on the drug packaging. To implement the simplest pharma serialization, you need the following information.
GLN and GTIN: You can easily access this information by registering with the local GS1 organization in our country. GLN is your global address where you operate, and GTIN is the unique complement of your products around the world.
Serial number: A numeric or alphanumeric character sequence consisting of up to 20 digits and must be unique for each GTIN.
Lot information: A company-specific production used during the manufacture of the drug is complementary.
Expiration date: The area indicating the expiration date of the drug.
For example: Let’s set this GTIN code as “08681986060022” for the imaginary VISIOMENTIN drug we produce. Let the expiration date be “01/31/2025” and “TRT001” in lot information. When we add the serial number “104001001” to this three information and print the resulting code on the drug with a data matrix according to the GS1 guidelines, we will have the simplest pharma serialization. The in the middle means group separator. The group separator is a special character that allows the shareholders to parse the data matrix code.
We have mentioned that there are small differences between countries’ pharma serialization rules. The example we have given is the standard implementation of GS1. While Turkey is fully implementing the simplest pharma serialization with the simplest format of GS1 in ITS, it has added special areas related to reimbursement institutions to the formats of DSCSA of the United States and the EU-FMD of the European Union. Russia, on the other hand, has a cryptographic area in the CRPT implementation with serial numbers added by the state.
In addition, the packaging practices of pharmaceutical manufacturers in each country differ significantly. While they sell medicines in plastic bottles in the USA, in Europe they generally sell medicines in cardboard boxes after they make blisters. Therefore, in order to implement the correct pharma serialization, you should first examine the regulations on pharma serialization in which country you manufacture for the pharmaceutical market.
What You Need to Know for Sustainable Serialization
GS1 Standards for Traceability
GS1 is a global organization with organizations in more than 100 countries. In the past, it has published standards defining the structure of barcodes often used in commerce, such as EAN and UPC, and has taken responsibility for global standardization. Today, it is developing standards on Data Matrix code structure and Electronic Product Code Information Services (EPCIS) on traceability. In addition, it has taken on the task of distributing GTIN and GLN codes to companies within GS1 countries.
Healthcare Group carries out studies on pharma traceability within the GS1 organization. This provides great benefits in pharma serialization. Please click here to reach the standards of the organization.
What is the Most Popular Serialization Method?
The most commonly used method for serialization in the pharmaceutical industry is undoubtedly Thermal Inkjet and labeling technology. With Thermal Inkjet, you can print 2D Datamatrix on many different surfaces at high speed and resolution. Labeling, on the other hand, is a great savior for packagings such as nylon bag, serum, and bottle, which cannot be printed directly. We use CIJ, Thermal Transfer, Robotic labeling, and CO2 Laser technologies for special serialization implementations in the pharmaceutical industry.
The Importance of Image Processing Technology in Serialization
In order for a drug to be traceable, its unique codes on the packaging must be readable within the supply chain. For this reason, it is very important to check the quality of the 2D code printed on the packaging and the quality of the human-readable text during serialization. You can use ISO 15415 for 2D codes and OCR / OCV technology for human-readable codes. It is necessary to use image processing equipment with different qualities for each type of packaging.
Validation Blended with GAMP5 and 21 CFR Part 11
Serialization projects made it compulsory to use computerized systems on production lines. The pharmaceutical industry controls the operation of a computerized system and the accuracy of these safety functions by preparing tests according to these two standards. You should use these two standards when preparing validation documents that will evaluate the entire process from the order of the system to the commissioning.
Notification of Data
The serialization operation for drugs produces a large volume of data. In order to ensure traceability within the supply chain, it is necessary to transfer this data to the customer or authority. Notifications must take place with guidelines provided by the authority or an EPCIS-like data template (usually XML), which the industry decides amongst themselves. Otherwise, players in the industry would have spoken different languages during data exchange, and traceability would become chaotic for the industry.
Management of Serialization Projects
Projecting on serialization requires knowledge and experience on this subject. We recommend you to read our article titled “What You Need to Know About Pharma Serialization Project Management”.
Aggregation – The Process That Is Always Forgotten
When designing serialization for tertiary packages, forgetting aggregation will restrict the movement of your products within the supply chain. This restriction can even lead to loss of sales. We recommend you to read our article titled “The A – Z of Pharmaceutical Aggregation” that describes the issue of aggregation with all the details.