RISK ASSESSMENT OF CHANGE OVER IN PRODUCTION FACILITIES OF MRNA AND VLP BASED VACCINES AT FORMULATION AND FILLING STAGES OF FINAL PRODUCT,

• Main Author: Shandy
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/78370
• Institution: Institut Teknologi Bandung

In the context of efficiency in terms of investment and accelerating timeline for providing products to the market, several strategies that can be implemented by biopharmaceutical industry in Indonesia include the use of multi-product production facilities. However, the risk of cross-contamination is a major challenge in multiproduct facility changeover activities. Referring to regulations such as ICH Q9, CPOB 2018, and EU GMP, scientific and rational proof through a quality risk assessment (QRM) needs to be carried out by the industry regarding the ability to use multiproduct facilities before carrying out the changeover process. This study aimed to conduct a QRM to identify risk aspects, to define risk values, to assess risks, to classify risk levels, to develop recommendations for improvement, and to compare risk values based on recommendations. QRM was carried out using the Failure Mode Effect Analysis (FMEA) method for the changeover process of mRNA (Covid-19 vaccine) and VLP (HPV vaccine) multi-products facilities at the formulation and final filling stages. Risk identification was performed by considering regulatory factors, product nature and characteristics, product safety, and production facilities. Based on the risk assessment, the highest initial Risk Priority Number (RPN) value is 12 with a Major risk level. Several recommended actions related to production schedules, utility systems, Personal Protective Equipment (PPE), and Contamination Control Strategy (CCS) are adequate to reduce the RPN value to 6 with an acceptable Major level. Based on the risk assessment from this research, formulation and final filling facilities can be implemented for multi-product of mRNA and VLP vaccines.