Serialization- a Notable Undertaking for Pharmaceutical Manufacturers

Serialization- a Notable Undertaking for Pharmaceutical Manufacturers

By Pharma Tech Outlook | Friday, November 30, 2018

Pharmaceutical manufacturers face compliance issues due to their complicated supply chain; this is where serialization comes to the rescue. Serialization is the process by which products are given a unique alphanumeric code which helps to enhance supply chain security. It necessitates pharmaceutical manufacturers to invest in newer technologies and ensure that the entire working line understands the new regulatory environment.

Serialization needs three components: an understanding of all products distributed through the supply chain; an understanding of all parties that participate in the supply chain; and a tool to identify and ensure the understanding among parties that participate in the supply chain. To achieve this agreement and then to implement it, is a notable undertaking. It demands the execution of processes and software to generate, affix, and capture the data related to alphanumeric codes. It may also require the potential reconfiguring of packaging lines, which takes time to install and validate.

Pharmaceutical manufacturers face the obstacle to meet global compliance due to the intricate regulations, system integrations, and costs associated. Acknowledging the complexity of regulatory requirements, organizations embarking on the serialization journey should embrace a comprehensive approach:

Serialization is a business continuity risk that leaves no stones unturned. However, there might be consequences that could mar the business performance. So, an executive sponsor should be appointed to lead the holistic approach. The other responsibility of the organization would be to convene a Multi-Disciplinary Team (MDT) to frame a guideline of how serialization can be applied across multiple organizational boundaries. The job of an MDT would be to actively engage representatives from manufacturing, supply chain, IT, and partner/contract management.

Serialization requires bar code that includes four lines of data— the unique identifier or Global Trade Item Number (GTIN), serial number, batch number, and expiry date. Having said that, many Indian pharmaceutical companies, while serializing, may not be applying numbers that are internationally compliant. However, today’s serialization demands that organizations are registered with the global standards authority GS1.

The other aspect of serialization is choosing the right software. Quality, data validation, and network connectivity are three factors essential to consider when selecting the relevant software. Good Manufacturing Practice guidelines state that users of computer systems must always be in control. Yet, multi-tenant serialization solutions (where multiple independent entities share the same instance of a software solution) can leave users out of control by imposing software updates without a prior update. Whereas, license-holding companies need to ensure that risk assessment processes are in place to monitor and adapt to change. When it comes to data validation, users should never deduce that the data entering or generated within, is clean and flawless. 

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