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Risk Analysis of a Manufacturing Process MPR was chosen by a large pharmaceutical manufacturer to manage the technology transfer of specialized manufacturing process information and knowledge from an existing overseas manufacturing facility to a new production site. MPR was also tasked to incorporate process changes to improve product quality,process and equipment reliability. In addition to developing a comprehensive technology transfer plan, MPR defined and characterized the manufacturer’s existing processes by creating flow diagrams, narrative descriptions, and process risk assessments to identify critical process parameters. MPR also identified and evaluated proposed process improvements and performed a risk analysis for each element of the manufacturing operation to prioritize resources to address knowledge gaps. The pharmaceutical manufacturer’s senior management recognized the value added by MPR’s risk-based process approach and have since adopted this method to other facility and process changes. |
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