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what is serialization pharmaceutical packaging

what is serialization pharmaceutical packaging

what is serialization pharmaceutical packaging插图

Track Trace Serialization
Track Trace Serializationin pharmaceutical packaging is the process of assigning unique markings on the packaging design of each product. It is essential to combat counterfeiting.

What is serialization in pharmaceuticals?

Serialization in pharmaceuticals involves tracing the product’s origin, Batch details, like the Batch number and Expiration date via the unique serial number from the manufacturer to consumers. The manufacturer will produce a serial number for products and apply on different batches via printing on labels and carton with barcode system.

What are the benefits of serialization packaging?

Serialization packaging benefits every level of the value chain, from production to distribution. By partnering with Nosco, pharmaceutical companies can help reduce fraud and keep consumers safe. Improve patient safety.

What is a serialized National Drug Code?

The Food and Drug Administration guidelines recommend the employment of standard numerical identifiers (SNRIs); during this, the serialized national drug code (sNDC), which is the NDC combined with a singular serial range. the entire process of Serialization in pharma has involve following stage:

What are the challenges of serializing a product?

Serializing product requires upgraded packaging lines, and those upgrades involve their own set of challenges and decisions, including: Equipment. You will need to determine new equipment needs. Will your current printers, for instance, be able to produce the required 2-D bar codes? And are your vision systems up to the challenge?

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.

What are the differences between countries in pharma serialization?

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.

What organization is used for 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 in 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.

What is a GLN and a GTIN?

GLN is your global address where you operate, and GTIN is the unique complement of your products around the world.

What is GS1 in business?

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.

Why is serialization important in pharmaceuticals?

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.

What are some examples of 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”.

Why is Nosco important?

It is essential to combat counterfeiting. Individual items, cases or pallets can be serialized by labeling for barcode scanning. Nosco solutions are cost-efficient and prevent companies from wasting resources on mistakes. Utilize Nosco’s serialization team to help develop and implement integrated packaging solutions.

Why is serialization important?

By partnering with Nosco, pharmaceutical companies can help reduce fraud and keep consumers safe. Improve patient safety. Inaccurate or fraudulent labeling puts patients at risk.

What countries does Nosco work with?

Meet multiple country requirements, including the U.S., Brazil, Italy, Turkey, Korea and China, with Nosco’s extensive experience in serialized printed packaging. Our superior On-Demand Solution Center gives us the tools to provide unique codes printed by our HP Indigo 30000 press.

How does digital printing reduce costs?

Reduce costs through increased efficiency. The digital printing process is quick and accurate, prioritizing optimal grading so serialization is easy to read and scan with inventory equipment. This saves time and money.

Why serialize pharmaceutical products?

Comprehensive serialization improves accuracy and proper tracking.

Why do companies partner with Nosco?

By partnering with Nosco, companies gain the tools, knowledge, educational materials and strategies they need to stay compliant with changing regulations. We adhere to the highest standards in labeling so your packaging falls well within regulations and better serves your consumer base.

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.

What are the challenges of serialization?

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.

Why is it necessary to establish the relevant links between each phase?

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.

What is 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.

What happens if the performance of the packaging line is reduced?

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.

Why is regulatory compliance important?

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. Inno4Life.com

How many manufacturers, distributors, and consultants came together to discuss problems in the healthcare supply chain in the United States?

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.

What is serialization in pharmaceuticals?

Serialization is a complex process that will have a ripple effect throughout operations at both pharmaceutical companies and their contract manufacturing and packaging partners. The process of implementing serialization in your company—whether you represent a pharma company or an outsourced partner—goes far beyond creating a number and affixing it to the side of a package. Serialization introduces a paradigm shift for the industry. As a manufacturer, your company has been focused on producing identical units to an exacting standard. With serialization, the focus evolves to producing that same product, identifying each item with unique data, communicating that data to supply chain partners, and then—depending on your supply-chain role—potentially accounting for that data for several years to come.

What are variable demands?

Variable demands. If you provide contracted manufacturing and packaging services, you likely serve numerous pharmaceutical customers. Because each of them has a unique set of internal systems, each of them will have unique and complex integration demands around mapping, event choreography, transmission protocols, validation, and more. Collecting, understanding, and implementing these demands from clients who have no intention of following any sort of standard will add untold time and effort to your process.

What are the two major projects that must be addressed in order to produce product in a serialized world?

In order to produce product in a serialized world, two major projects must be addressed: lines upgrades and trade partner integrations. Let’s consider what’s involved with each, what additional questions they raise, and where to get started.

Why do pharmaceutical companies need to change their labels?

Many pharmaceutical companies are finding that label changes are required in order to make room for the 2-D bar codes and any human-readable components. When that’s the case, time must be built-in for both the redesign work and the FDA approval of the revised layout.

How many prescription medications are protected by law?

By 2019, more than 75% of the world’s prescription medications will be protected by legislation. While no two countries have passed the exact same requirements, they all rely on one core component: serialization.

How many countries have track and trace laws?

By Graham Clark, TraceLink. In response to increasing drug integrity concerns, more than 40 countries have introduced track-and-trace laws to help regulate product as it passes through the supply chain. By 2019, more than 75% of the world’s prescription medications will be protected by legislation. While no two countries have passed …

Is serialization a problem?

Simplify your approach. Serialization in today’s global supply network is inherently a network data exchange problem, which means relying on traditional technology for partner communications will be a painful—and potentially untenable—option. Look toward new technologies for a shared platform or network data exchange solution that would reduce individual connections and mitigate unique partner demands.

What is URS document?

A user requirement specification (URS) document is the first reference document built when a serialization project is initiated. URS documents are also needed when an existing system must be modified to comply with new regulations.

What is serialization in pharmaceuticals?

Serialization is one of the biggest information technology (IT) challenges to affect the pharmaceutical sector in the last decade. In a global landscape of constantly evolving regulatory, market, and technical requirements, serialization is, and will likely remain, a complex topic for all industry actors.

What is a good approach to RFQ?

A good approach is to define criteria to measure how requirements are achieved. These criteria can be used to evaluate whether vendors that participate in the RFQ process provide proposals that reflect the business need as closely as possible. Additionally, these criteria could be used as benchmarks during the implementation phase.

When a preferred or preselected vendor is identified before the RFQ, what is the URS provided with?

When a preferred or preselected vendor is identified before the RFQ, the URS provided with the vendor’s standard commercially available solution could be used. This approach is especially relevant for many of the Level 3 serialization solutions available on the market, which already include standard URS in their documentation. Even if standard URS are available, the user should perform their own risk assessment to ensure that they adequately understand the complexity and novelty of the scope of functionalities to be purchased.

What is the purpose of serial number?

Tools to help track and trace stock: The serial number can also be used to track stock in the supply chain from the manufacturer to the final patient, as well as to trace products returned to any part of the supply chain.

How many principles are there for data quality?

Data quality can be expressed through six principles:

Why is energy requirement important?

Energy requirements: It is important so specify voltage and frequency, waveform, protection against voltage drops, and other energy-related matters.