What You Need to Know About Serialization Project Management in Pharma Industry
One of the products with the highest utilization rate in the world is undoubtedly medicines. This rate sometimes causes drugs to be absent from the market and patients to lack the necessary treatment. This is why the industry has been fighting global counterfeiting and black-market activities for many years using serialization. In the recent COVID-19 pandemic, we have all witnessed the scale of these illegal activities. These illegal activities harm public health and cause the loss of prestige of the manufacturing companies.
Last decade, OECD countries have been trying to enact and enforce laws in their countries to combat drug counterfeiting. More than half of these countries enacted laws to ensure pharma traceability and motivated their industries for serialization. Also, legislators of countries outside the union followed these studies and started to combat illegal activities in their countries.
Countries will restart accelerating their post-pandemic pharma traceability studies to overcome the supply chain problems during the COVID-19 pandemic.
Therefore, companies will need to comply with the regulations prepared by legislators on pharma traceability in a short time. In this article, we have addressed considered issues to be in the projects to ensure compliance with the regulations.
What is Serialization in the Pharma Industry?
Serialization in the pharmaceutical industry is the assigning of a unique serial number to each level of packages.
When the related code is printed on the package with a data matrix (2D) or barcode (1D), the drug becomes traceable throughout the supply chain. Once the drug is traceable, its movement within the supply chain is electronically recorded throughout its life cycle with a track and trace system. It is no longer possible for the drug, every movement of which is recorded, to be subject to illegal activities.
What are the Key Points of Serialization Projects?
The common problem in serialization projects is a failure or partial success. Or, the project cannot be completed at the time that needs to be completed. In this section, we tried to share the key points of a successful serialization project with you.
The Correct Project Team
You must give duties and responsibilities to the representatives of production, quality, information systems, finance departments within the project. When choosing team members, take care that they are competent to understand the needs of each other’s workspaces. The project team leader’s detailed presentation on serialization, and sharing useful documents will increase the team’s knowledge and motivation.
The Correct Project Management
The project team should organize regular meetings and follow the project on a schedule. You should determine the milestones of the project. Also, you should develop action plans for the delays that will occur at the milestones.
The Correct Determination of Requirements
A properly prepared URS document in serialization projects will bring absolute success. While preparing URS, it should be plain and original. When you use sample URS document of supplier or competitor directly, you drift away from identifying your own needs. However, you can use sample documents to identify missing points and improve the analysis capability after you have identified your specific needs. Also, note that any of your requirements other than industry-accepted standard functions make your project more complex and expensive.
Understanding the Value of the Data
Everyone involved in the project needs to understand the value of the data very well. The data is also produced along with the drug on the production line. Regardless of the quality of the drug produced, incorrect or incomplete data during serialization will aggressively block sales figures.
Choosing the Supplier
The first rule of choosing the right supplier is to make a comparison between the suppliers correctly. You should evaluate the capacity to meet project requirements fairly when choosing a supplier. To secure justice, remember to determine the transparent and specific requirements. You can use comparison tables to make these evaluations.
60% of serialization projects are software, 30% are hardware and 10% are validation operations. Therefore, the supplier you choose must have knowledge and experience in developing software projects.
The Correct Equipment Investment
The serialization process should not create a bottleneck for production lines. Because in the pharma industry, the OEE value of production lines is often followed. When investing in equipment, you should choose equipment compatible with the speed of the production line, or even with a little extra serialization capacity. Otherwise, you will monitor unacceptable changes in the OEE value of the production line.
Seeing The Big Picture
Even if you manufacture locally, you have to think globally. Manufactured drugs may be desired to use any time to meet an urgent need at some point in the world. The serialization regulations of the country are constantly changing. So, the software and hardware used in the project should be easily updated according to the new regulation needs.
In the pharma industry, validation studies must guarantee that every equipment performs its full function. Keep in mind, you should examine more software concepts than equipment in the validation studies of serialization projects. Try including colleagues, who trained in software and have adopted the rules of GAMP5 standards, in your quality team.
Integration with Third-Party Systems
Remember, over time you need to develop third-party software integrations with your partners’ systems and authorities of different states.
Remember The Aggregation
The fundamental mistake in serialization projects is not to put pharma aggregation on the agenda while determining requirements. Every serialization operation has to be integrated with the aggregation process in the future. Otherwise, you cannot monitor the movement of drugs within the entire supply chain.
In this article, we tried to summarize what you need to know for a successful serialization project in Pharmaceutical Industry.