When implementing a serialization strategy, many factors need to be considered from the planning stages itself, such as the locations, production lines, and relevant markets. Without considering these points, it could result in costly delays and could affect the production lines, which would result in further substantial losses. Businesses must prepare solutions and plan for complexities at the early stages of their serialization implementation. They need to keep in mind costs and investments for training, new equipment, country specification requirements, and systems integration.
A way to efficiently plan for serialization is to be prepared for the different operational serialization problems. Here are the top three most common challenges:
1. Financial and Investment Costs
When a company is looking at implementing and maintaining serialization, costs that are both financial and operational are a big concern. Especially for those businesses that are smaller in scale and may not have the necessary resources or funds for new equipment, software and maintenance expenses. A way to overcome this hurdle is to look at standardizing operations and practices at all stages and across different locations.
2. Growth and Scalability
To avoid operational obstacles that could lead to delays, pharmaceutical manufacturers must ensure that their planning strategy includes processes and systems that are kept up to date and are compliant to make sure there’s business continuity. As regulation requirements differ from country to country, the supply chain must be able to adhere to these regulations and prevent counterfeit drugs from entering the marketing. Companies must understand the country-specific regulations, tracking requirements and they should also keep in mind the regional operational differences.
3. Supply Chain Blockages
The supply chain can face bottlenecks caused by added serialization related manufacturing and packaging stages, new data and track and trace systems that require verification and administration intervention (especially during scanning and validation stages). In case a product is damaged or faulty, then aggregation adds to bottlenecks and identifies, tracing, and then removing the product will cause further setbacks. Companies need to plan and understand possible future issues while also making sure communication between all networks at all stages flows freely. All the various systems will need to liaise with each other and keep necessary measures in place for secured data exchange of sensitive information. Since the network must be able to support data from multiple sources and different geographies, it’s crucial for project testing to be done in the early stages to identify the problem areas in the setup.
In conclusion, communication, effective project management is critical to ensure a seamless serialization process is in place; especially when the regulations come into force. It’s also essential to have the necessary processes and systems running efficiently, which will provide more grounds for serialization success.