Global Serialization Standards and Their Impact on the Pharma Supply Chain

Serialization has become a vital tool to improve the security and integrity of the pharmaceutical supply chain in a time when the pharmaceutical sector is confronted with issues like as theft, counterfeiting, and regulatory compliance. The process of serialization entails giving each unit of sale a unique identification that allows for tracking and traceability along the whole supply chain. The enormous effects of worldwide serialization rules on the pharmaceutical supply chain are explored in this blog.

Recognizing Pharma Industry Serialization:

In the pharmaceutical sector, serialization is the process of giving each product unit, usually at the carton or bottle level, a unique serial number. Usually, this special code is a component of a bigger code, like a 2D barcode or a QR code that has further details about the goods, including the batch number, expiration date, and production date.

Need for Serialization in Pharma Supply Chain:

The pharmaceutical industry's use of serialization is driven primarily by the following factors:

Prevention of Counterfeit Drugs:

• The public's health and patient safety are at serious risk by counterfeit pharmaceuticals.
• Tracking genuine items and identifying counterfeit ones are made possible by serialization.

Regulatory Compliance:

Various regulatory bodies have varying criteria for pharmaceutical items supplied inside their boundaries; hence serialization rules vary across different locations. Among the essential serialization standards are:

United States (DSCSA):

• The Drug Supply Chain Security Act (DSCSA) demands that wholesale distributors, dispensers, repackagers, and pharmaceutical manufacturers establish a system that permits the tracking and tracing of prescription pharmaceuticals in the United States.
• The National Drug Code (NDC), serial number, lot number, and expiration date must all be included in a unique product identifier, as required by the DSCSA.

European Union (FMD):

• The primary objective of the Falsified Medicines Directive (FMD) is to stop counterfeit medications from entering the authorized supply chain.
• On the outside packaging of medications, the FMD mandates the use of an anti-tampering device (ATD) and a unique identification (UI).
• A product code, serial number, batch number, expiration date, and national reimbursement number are all included in the user interface.

China (CFDA):

• To increase traceability and fight counterfeiting, the China Food and Drug Administration (CFDA) requires the adoption of serialization.
• Medicinal goods need to be registered in a centralized database kept up to date by the CFDA and have a unique identification included.

Russia (MDLP):

• Pharmacies are required to serialize their goods with a unique identity in accordance with the Russian serialization rule, the Monitoring of the Movement of Medicinal goods (MDLP).
• Each product's journey through the supply chain is tracked and recorded by the MDLP system.

Impact of Serialization on the Pharmaceutical Supply Chain:

Serialization offers several advantages and completely changes the pharmaceutical supply chain.

Enhanced Security:

• By adding a layer of protection through serialization, counterfeit goods find it more difficult to infiltrate the supply chain.
• At different stages of the supply chain, stakeholders may confirm the legitimacy of items thanks to unique IDs.

Better Traceability:

• End-to-end traceability made possible by serialization makes it possible for stakeholders to follow the flow of goods from the point of manufacture to the final customer.
• This openness aids in recognizing and resolving problems like theft, diversion, and counterfeiting.

Regulatory Compliance:

• Pharmacies may avoid fines and limitations on their access to markets by adhering to worldwide serialization standards, which guarantee that regulatory obligations are met.
• Moreover, serialization makes it easier to share data with regulatory bodies, improving supervision and control.

Effective Recall Management:

• Serialization makes it possible to precisely identify and remove recalled items from distribution in the case of a product recall.
• As a result, recalls are less costly and of greater scope, safeguarding both the reputation of the business and its customers.

Supply Chain Optimization:

• By offering insightful information about supply chain processes, serialization data helps businesses better estimate demand, cut lead times, and manage inventories.
• Costs are reduced and operational effectiveness is raised as a result.

Patient Safety:

• Serialization contributes to patient safety by guaranteeing the validity and consistency of pharmaceutical items.
• Patients may rest easy knowing that the medications they are given are authentic and unadulterated.

Challenges in Implementing Serialization:

Implementing serialization in the pharmaceutical sector has drawbacks despite its advantages:

High Costs:

• The equipment, software, and training required to use serialization technology can all be expensive initially.
• The necessary resources may be difficult for smaller businesses to allocate.

Complex Integration:

World BI Pharma Supply Chain & Logistics Conferences:

Global serialization standards are vital for securing the pharmaceutical supply chain and ensuring product safety. Despite challenges, serialization offers significant benefits such as enhanced security, better traceability, regulatory compliance, efficient recall management, supply chain optimization, and improved patient safety. As the pharmaceutical industry evolves, serialization will continue to be essential for protecting the supply chain and public health. Pharma Supply Chain & Logistics Innovation Programme, which provides a platform for distinguished executives, Heads, and Vice Presidents (VPs) from different companies to come together with the common goal of promoting worldwide knowledge. Give us a call, message or email at World BI.

We look forward to assisting with all of your supply chain solutions.