A simple and effective guide to help you implement pharma serialization and traceability projects based on our experience, without drowning or getting lost in the attempt…
We provide traceability services since 2007. Verifarma started in Argentina, where drug traceability regulation came into force in 2011, and that gave us many strengths, knowledge and expertise on the subject.
To begin… no matter if your organization is big, medium or small pharma – whether you are almost serializing, have invested in serialization technology, or are hearing about it for the first time – these first steps can be taken to simplify the journey to compliance with new regulations around the globe and realize the long-term benefits of implementing serialization:
- PROJECT OVERVIEW
Serialization and traceability affects all departments of a pharmaceutical company. Therefore, organization and planning is key to determine a successful project.
Some manufacturers have multiple own and CMOs sites with multiple packaging lines in different geographies. It is important to identify the markets the manufacturer produce for, which products go for those markets, which sites manufactures those products, which lines are used to package those products. By mapping all these aspects from the beginning, the project becomes more manageable and it becomes easier to define timescales.
- PROJECT DEFINITION
Once you have mapped out the scope of the project, the number of locations, products and production lines, it is important to define the scope across the organization, because a serialization projects covers many areas of the company:
- IT for integration of existing software with track & trace solutions and reporting to regulatory authorities.
- Engineering: as packaging lines equipment must be upgraded.
- Packaging Engineering: Artwork and packaging adjustments to fit serialization needs.
- QA and regulatory affairs: to assure regulations compliance.
Last but not least, it is essential for the project success, to designate a Project Manager responsible for the Serialization and Traceability Program.
- UNDERSTANDING THE REGULATIONS
It is mandatory to know the current regulations for the markets in which the products are commercialized. Although the regulations are similar, there are variations, and it is key to identify the main aspects for each market: coding standards, identification, safety devices, products covered by regulation, communication and report to the supply chain and regulatory agencies, and deadlines.
- LIFECYCLE AND TROUBLESHOOTING SUPPORT
It is important to consider potential challenges after the project goes live. As nothing stays constant, global regulations keeps changing, with new markets introducing new legislation. Ongoing training and assistance for troubleshooting issues are critical to the successful running of serialization processes. Managing updates to systems is also key and this must be planned at the beginning of the implementation project.
Next post: Track & Trace without stress – Part II: DEPLOYMENT TIMESCALES, stage by stage – DON’T MISS!
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