DISCOVERLearning About Serialization Solution In Pharma

Learning About Serialization Solution In Pharma

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Pharma serialization provides a unique code to each drug’s packaging and prints that code on the packaging using any technique available. In this definition, there are two key points. The unique code is the first and the second drug package.

The meaning and structure of the unique code are outlined in each country’s rules. All countries’ rules have a special code description that is essentially identical to one another and follows GS1 standards. The areas that differ are often the reimbursement institutions’ preferred codes and cryptography. 

What Are The Prerequisites For Serialization In The Pharmaceutical Industry?           

Serialization requirements make it easier for pharmaceutical industry players to check medication product authenticity, discover and remove illegitimate or expired items from the supply chain and promptly manage drug product recalls.

Serialization in the pharmaceutical sector is one of the most effective methods available to society in the fight against counterfeit drugs. But what are the facts regarding this subject, and what do you need to know about serialization right now?

Counterfeit drugs put people’s health at risk. They are frequently ineffective and hence do not assist patients. If that wasn’t bad enough, counterfeit pharmaceuticals could also cause serious harm to patients, even death.

Counterfeit pharmaceuticals also harm the pharmaceutical business. They result in direct financial loss and unjustifiable reputational damage, loss of patient confidence, and other negative consequences.

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Factors To Consider For Pharma Serialization 

Cost

You’ll need to set aside money to upgrade your system so that you can add serial numbers to your products during production and manage the data that results. This includes the cost of developing software to enhance functionality and integrate systems and the cost of upgrading hardware.

Resources

You’ll also need to set aside funds to adopt serialization in your manufacturing process completely. Because there are no universally accepted worldwide rules that apply to the entire pharmaceutical sector. This includes gaining a thorough grasp of the consequences of serialization based on the global markets you serve and the goods you produce. You’ll also need resources to plan serialization installation properly, and some staff training will be required.

Choosing the Best Partner

Working with the proper partner is critical to any successful serialization implementation. This involves choosing a vendor-neutral software provider who can work with all of your platforms and equipment. It would help if you also looked for a company with experience with integration, serialization, and the pharmaceutical business.

Management Of Data

Your facility will require technologies that allow for the efficient storage of serialized data and quick and easy access to that data for users. You’ll need hardware, but you’ll also need excellent data management and reporting software. This will imply a custom solution that works in tandem with your current system in virtually all circumstances.

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Automation

Serialization will slow down production, especially during the packaging stage. After all, serial numbers must be added to each package. Individual product packages, case packages, and pallet packages are examples of this. Adding more automation to your line can help to mitigate this and, in some situations, make it more efficient than before.

Exchange Of Information

It is not enough to have data internally for serialization efforts to be successful. You’ll also need technologies to make secure data sharing with your supply chain and others possible.

Taking on the Problem of Fake Medicines

The solution is simple: eliminate the plague of counterfeit drugs from the planet. Anyone in the pharmaceutical industry, from producers to regulators, understands how much easier said than done is.

It is ineffective even showing up at a counterfeit manufacturing facility to shut it down. This is because medicines are virtually typically produced in stages at various places. Furthermore, it is very uncommon for these places to be in separate nations.

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Individual counterfeit manufacturing plants are likewise often modest. Because they have several small facilities, they can manufacture at a large scale. Put another way, if you shut down one, many more continue to run untouched.

Taking on the distribution side of the counterfeit drug problem is just as difficult, not least because many bogus drugs are distributed through the internet. The World Health Organization believes that up to 50% of pharmaceuticals marketed on the internet are counterfeit. Furthermore, around 90% of the pharmaceuticals supplied do not originate in the country that the selling website states.

Conclusion 

Serialization entails tracing each product from the manufacturer to the patient’s end-user using a unique serial number. The serial number contains information such as the product’s origin, production batch, expiration date, etc.

Obtaining unique serial numbers for your products, assigning them to each batch you produce, printing the serial number on the product’s label in the form of a barcode, and then managing the data so you can trace the product via the serial number are all steps in the serialization process in the pharmaceutical industry. This may be necessary months or even years after the product has left your production line.

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