Developing systematic assessment for manufacturing materials in a pharmaceutical company
Ziniauskaite, Agne (2025)
2025
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-202505079536
https://urn.fi/URN:NBN:fi:amk-202505079536
Tiivistelmä
The thesis focuses on establishing a systematic risk assessment procedure for manufacturing materials in a pharmaceutical company’s procurement department. The risk assessment procedure helps to rate manufacturing materials’ criticality for the drug based on pre defined risks.
The thesis started by discussing the theoretical framework related to procurement risks, risk assessment methods available, and analyzed pharmaceutical industry regulatory requirements for manufacturing materials. The research development parts relied on utilizing qualitative research methods, interviews and document analysis. The thesis used the 5x5 risk matrix methodology to improve the risk assessment tool. The department’s materials criticality was scored for pre defined supply chain risks and their impact on drug manufacturing. Subsequently, mitigation actions suitable for the company were applied, and the standardized risk assessment procedure was established.
After the development, the evaluation was complimented by incorporating a quantitative research method, a survey, to measure the success of the newly established risk assessment procedure. The results of the survey showed a high satisfaction with the newly established procedure. As the risk assessment procedure was established, the company can be consistent and thus can benefit from performing risk assessments for manufacturing materials on a yearly basis. The risk assessment procedure can be further revised according to the company's needs, adding new materials or suppliers.
The thesis started by discussing the theoretical framework related to procurement risks, risk assessment methods available, and analyzed pharmaceutical industry regulatory requirements for manufacturing materials. The research development parts relied on utilizing qualitative research methods, interviews and document analysis. The thesis used the 5x5 risk matrix methodology to improve the risk assessment tool. The department’s materials criticality was scored for pre defined supply chain risks and their impact on drug manufacturing. Subsequently, mitigation actions suitable for the company were applied, and the standardized risk assessment procedure was established.
After the development, the evaluation was complimented by incorporating a quantitative research method, a survey, to measure the success of the newly established risk assessment procedure. The results of the survey showed a high satisfaction with the newly established procedure. As the risk assessment procedure was established, the company can be consistent and thus can benefit from performing risk assessments for manufacturing materials on a yearly basis. The risk assessment procedure can be further revised according to the company's needs, adding new materials or suppliers.