Serialization projects in the pharmaceutical industry involve implementing a system that allows for the unique identification and tracking of individual drug products throughout the supply chain. Here are some steps to jump-start a serialization project in the pharmaceutical industry:
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Understand the regulations: Serialization requirements vary by country and region, so it is important to understand the specific regulations that apply to your product and market. For example, the US FDA DSCSA requires serialization for prescription drugs and some over-the-counter drugs, while the European Union EU HUB requires serialization for most prescription drugs.
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Define your project scope: Determine which products and packaging configurations require serialization and which markets you will be distributing them in. Decide which serialization technologies will be used, such as 2D data matrix codes or barcodes, and how the data will be captured and stored.
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Choose a vendor/partner: There are many vendors and partners that specialize in serialization solutions. Look for a vendor/partner that has experience in the pharmaceutical industry and has a proven track record of successful implementations.
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Develop a project plan: Create a detailed project plan that outlines the timeline, resources, and deliverables for the project. Make sure to include milestones for testing and validation.
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Establish a cross-functional team: Serialization projects involve many different departments and stakeholders, including IT, quality, supply chain, and regulatory. Establish a cross-functional team that includes representatives from each of these areas to ensure that everyone's needs are addressed.
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Test and validate the system: Once the system is implemented, it is important to test and validate it to ensure that it meets regulatory requirements and functions as intended. This includes performing mock recalls and other simulations to test the system's ability to track and trace products throughout the supply chain.
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Train employees: Ensure that all employees involved in the serialization process are properly trained on the system and its procedures.
By following these steps, you can jump-start a serialization project in the pharmaceutical industry and ensure compliance with regulations while protecting the safety and security of your products.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, partners and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
