Onboarding a New Contract Manufacturer into Pharmaceutical Serialization Process
Airola, Jussi-Pekka (2022)
Airola, Jussi-Pekka
2022
Tuotantotalouden DI-ohjelma - Master's Programme in Industrial Engineering and Management
Johtamisen ja talouden tiedekunta - Faculty of Management and Business
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Hyväksymispäivämäärä
2022-10-10
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-202209197137
https://urn.fi/URN:NBN:fi:tuni-202209197137
Tiivistelmä
Counterfeit medicines are a global problem that affects a wide variety of pharmaceutical products. The issue is very serious because counterfeits can fail to treat diseases and they can even be harmful to their users. Serialization is used to prevent them from reaching consumers. For products sold in the European Union, which is the focus of this study, serialization is used to give each prescription drug a unique identifier as required by the Union’s regulations. The authenticity of the products can be verified throughout the supply chain when they are serialized. In order to do this, brand owners and their contract manufacturing organizations must co-operate to serialize products and upload the corresponding serialization data to the European repository system. When a new contract manufacturing organization starts producing products that must be serialized, they must be onboarded into the brand owner’s serialization process to ensure that the products will fulfil the serialization requirements. This research studies how a new contract manufacturer is integrated into the said process.
This study was done as a pragmatic case-study for a case company. The company in question is a global pharmaceutical company that manufactures eye medicines. In the study, the process of onboarding a new contract manufacturer is researched along with what kind of challenges this kind of process includes. No previous research was identified to exist on this topic. The study began with a literature review of the relevant legislation, serialization, and system requirements. It was then used to create an extensive theoretical framework about serializing pharmaceutical products in the European Union. After creating the framework, empirical data was gathered through interviews. Additional empirical data was gathered through observations. Finally, empirical data was compared to the literature framework to answer the research questions.
The study's results clearly define the process of onboarding a new contract manufacturer into pharmaceutical serialization process. The onboarding process itself is divided into seven stages, all of which are described in detail in this study. Results indicate that even though the process is very straightforward, it includes several challenges. First, the data and information shared between the brand owner and a CMO can include errors, which are often caused by a lack of communication, clear instructions, and unfamiliarity with the other party’s system. According to the findings of this research, these challenges make it especially difficult to establish a working connection between the systems and to successfully complete the test phase. A second clear challenge in the process is its large number of dependencies. These dependencies can be either internal or external. Due to this, multiple actions in the process can only be started after other parties have completed the necessary actions on their side. It was identified that both of these challenges can be overcome by communicating more clearly the onboarding process and the data requirements to the new manufacturer. One way of achieving this would be to hold a shared workshop with them. In addition, it was observed that involving stakeholders more in the process could be used to increase its transparency and reduce the impact of dependencies. A template was also created during the study that can be used to gather the necessary data from new contract manufacturers and give them instructions about the data requirements.
This study was done as a pragmatic case-study for a case company. The company in question is a global pharmaceutical company that manufactures eye medicines. In the study, the process of onboarding a new contract manufacturer is researched along with what kind of challenges this kind of process includes. No previous research was identified to exist on this topic. The study began with a literature review of the relevant legislation, serialization, and system requirements. It was then used to create an extensive theoretical framework about serializing pharmaceutical products in the European Union. After creating the framework, empirical data was gathered through interviews. Additional empirical data was gathered through observations. Finally, empirical data was compared to the literature framework to answer the research questions.
The study's results clearly define the process of onboarding a new contract manufacturer into pharmaceutical serialization process. The onboarding process itself is divided into seven stages, all of which are described in detail in this study. Results indicate that even though the process is very straightforward, it includes several challenges. First, the data and information shared between the brand owner and a CMO can include errors, which are often caused by a lack of communication, clear instructions, and unfamiliarity with the other party’s system. According to the findings of this research, these challenges make it especially difficult to establish a working connection between the systems and to successfully complete the test phase. A second clear challenge in the process is its large number of dependencies. These dependencies can be either internal or external. Due to this, multiple actions in the process can only be started after other parties have completed the necessary actions on their side. It was identified that both of these challenges can be overcome by communicating more clearly the onboarding process and the data requirements to the new manufacturer. One way of achieving this would be to hold a shared workshop with them. In addition, it was observed that involving stakeholders more in the process could be used to increase its transparency and reduce the impact of dependencies. A template was also created during the study that can be used to gather the necessary data from new contract manufacturers and give them instructions about the data requirements.