Pharma Serialization - What You Need to Know ?

Pharma Serialization – the process of assigning a unique identifier to pharmaceutical products to ensure authenticity and safety. This system allows regulatory bodies to trace and track the origin of medicines in case of any issues.

Key updates with SEN Pharma about Pharma Serialization – Have you know yet:

EU Directive 2011/62/EU mandates serialization for all prescription drugs circulating in Europe.
Starting in 2019, prescription drugs (ETC) failing to comply with serialization requirements are no longer permitted in the European market.
Future plans may extend serialization to OTC products within Europe.

Pharma Serialization – “A unique code for each saleable unit on pharmaceutical packaging”—is increasingly applied, but how well do you understand the systems and processes involved ?

You can read more in the previous article for a general overview: Serialization – An effective solution to prevent counterfeits

1. Serialization System Architecture

Serialization rules may vary across countries, requiring manufacturers to adopt precise formats for serialized data when printing QR codes on packaging for products intended for commercialization.

While the Global Location Number (GLN) uniquely identifies the manufacturing entity and the Global Trade Item Number (GTIN) specifies an individual product, additional information needed for QR code generation differs based on production batches and the country where the product will be distributed. Consequently, manufacturers must navigate a complex production workflow, structured across five levels of technology, to complete the serialization process effectively:

Hệ thống kiến trúc quá trình serialization — **Serialization System Architecture**

Level 1: Smart Devices; Collect product data needed for serialization directly at production or packaging points.
Level 2: Packaging Lines; Automated systems for packaging products and applying serialized codes.
Level 3: Manufacturing Plant; Responsible for initial serialization steps during production.
Level 4: Enterprise; Centralized management systems for serialization activities across the organization.
Level 5: Regulatory Authorities represent the highest tier in the system architecture, encompassing regulations, policies, and procedures that govern the global implementation of serialization systems. This level plays a pivotal role in ensuring the consistency, compliance, and transparency of the serialization process across the entire supply chain.

2. Implementation Methods in Pharmaceutical Manufacturing:

Manufacturers adopt two main approaches to serialization, depending on cost, regulatory compliance, complexity, and efficiency,…

In-Line Serialization and Label Serialization

3. Benefits and Challenges of Serialization

The implementation of serialization in the pharmaceutical industry brings numerous benefits to various stakeholders, including:

Patients: Patients can have peace of mind knowing they are using genuine and safe medications.
Manufacturers: Manufacturers can safeguard their brand and reputation while minimizing losses caused by counterfeit products.
Regulatory Authorities: Regulatory authorities can more effectively monitor the market, protect public health, and ensure the integrity of the pharmaceutical supply chain.

However, several challenges persist for businesses looking to implement serialization, which include the following:

Redesigning Labels: Manufacturers may need to revamp labels to accommodate new barcodes.
Maintaining Production Efficiency: Labeling and scanning might slow packaging lines, necessitating increased automation or manpower.
Data Management: IT systems must handle the creation, storage, and transmission of vast serial data across supply chains.
Cross-functional Teams: Collaboration between IT, packaging, labeling, QA, and project management is essential for seamless implementation.
Investment Costs: Upgrading equipment, software, and training incurs significant expenses.

With undeniable advantages, serialization is being widely adopted in the pharmaceutical industry worldwide. However, it also brings certain challenges, such as the significant investment required for new systems and processes, as well as the need to comply with complex regulatory requirements.

Businesses must thoroughly understand serialization mandates and implement appropriate solutions to ensure compliance while maximizing the benefits of this critical system.