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How a CDMO Helps With Serialization Compliance

Nov 03, 2017
Article > A Fighting Chance: Looking At How A CDMO Can Help With Global Serialization Compliance

Article > A Fighting Chance: Looking at How a CDMO Can Help with Global Serialization Compliance

by Mario Scigliano & Christian Ahlmark

European Pharma Manufacturing, November 2017

Packaging is integral to the fight against counterfeit medicines and serialization of packaging is an essential tool with which companies and customers can use to verify drug products. Here, Mario Scigliano, serialization & automation manager, and Christian Ahlmark, associate director, sales & key account management, CordenPharma, discuss how a CDMO can help give companies a fighting chance to be globally serialization compliant.

Packaging is the key to combatting the worldwide drug counterfeiting problem. Nearly 10 years ago, the primary target for drug counterfeiters were lifestyle drugs, such as Viagra. Now, commonly-used and lifesaving medications, including insulin, cancer drugs and cardiovascular medicines, have fallen victim to phony manufacturers. This poses a pressing danger to consumer health. The World Health Organisation (WHO) estimates that the rise in counterfeit drugs is responsible for up to one million deaths annually, and that 1 in 10 medicines sold worldwide is counterfeit, a figure that can reach up to 7 of 10 in some countries.1

Medicines need to be packaged in a way that allows counterfeits to be quickly and easily identified, preventing their circulation and/or eliminating drug recalls. Essential to this is package serialization, which establishes a unique identifier that assures each member of the supply chain (from manufacturer to patient) the drug product is not counterfeit.

This November, US pharmaceutical companies must meet new serialization compliance deadlines aimed at combatting global counterfeiting efforts. The criticality of serialization should rather be viewed as a clear benefit for patient safety, which can also be turned into a competitive advantage for the pharmaceutical industry.

If your manufacturing is outsourced to a contract development and manufacturing organization (CDMO), they must understand the functionality and necessity for serialization and help navigate through the myriad of global serialization guidelines.

As a full-service global CDMO, CordenPharma determined that in order to better service pharma customers, the drugs produced must comply with multiple market requirements worldwide. China, for example, made serialization mandatory for certain pharmaceuticals in 2008.

Serialisation in the supply chain

So how can these counterfeit medicines avoid detection in such a highly regulated and scrutinised industry? The Achilles heel of the pharmaceutical industry lies in the supply chain, with almost 40% of the drugs that supply the US market being manufactured overseas, and the active pharmaceutical ingredient (API) itself being imported from over 150 different countries.2

This supply chain is incredibly complex, with some drugs passing through 10 or more points of contact before reaching the patient. All stages of drug manufacturing and supply are vulnerable to drug counterfeiters. Supply chain players are working together to integrate serialized anti-counterfeit features into pharmaceutical packaging. Serialisation is a unique identifier issued for a particular manufacturer and a specific product. Some serialization techniques include:

More than 55 countries have chosen to implement serialization and track-and-trace measures to prevent counterfeit drugs from reaching the market.3 By 2018, while more than 75% of the world’s prescription medications will be protected by serialization, no two countries have passed exactly the same legislation, thus complicating the implementation process.

A CDMO can implement aggregation as part of its serialization system. Through harmonising production lines, it is possible to make them capable, efficient and able to support full aggregation. The aggregation data then enables improvement of internal visibility into product movement, inventory, warehousing and shipping. Additionally, any rework, recalls, or returns can be handled in a more controlled environment because the serialization and aggregation data allows for quicker access to the drug product.

One language, multiple markets

Each country determines its own specifications in terms of serialization and anti-counterfeiting. The guidelines in some countries are limited, and leave manufacturers to decide on the information content. Fortunately, a standard language for communicating serialized information already exists. The foundation of this language is a GS1 standard, called Electronic Product Code Information Services (EPCIS). The serialization and traceability industry is aligned, using EPCIS as the de facto standard, allowing an effective and efficient communication format.4

At CordenPharma, for example, we employ a team to standardise processes and logistics while also maintaining the integrity of the data according to the specifications issued by various ministries of health and GS1. Countries that are using GS1 standards give the consumer confidence that their drug product is kept safe and secure throughout the supply chain. Countries that do not apply such standards will continue to have counterfeiting issues.

The benefits of partnering with a CDMO

When it comes to choosing a CDMO to handle your serialization efforts, be certain that the partner will:

  • >> Guarantee secure packing for each product shipped. Assurance that each product is reliably protected against transportation and environmental stress. Advanced materials and packing technologies are deployed for special products, such as oncological products.
  • >> Safeguard the patient from counterfeit medicines using systems applied to prevent the opening of the drug product and ensuring the product quality.
  • >> Manage large quantities of data throughout the supply chain. Use current technology to monitor the drug product location at any time.
  • >> Have processes and procedures in place for handling exceptions, rework, repackaging, returns etc. that could impact the integrity of the associative drug company parent-child hierarchy.
  • >> Adapt to the most current standards and be flexible in transposing regulatory market requirements, while providing customers the utmost level of support. The goal is to keep patients safe.

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