Agile Machine Qualification in Pharmaceutical Production

This case study details the Agile Machine Qualification approach utilized by Körber Consulting to assist a leading global pharmaceutical company in expediting machine qualification. The objective was to enable the customer to begin production four weeks earlier than initially planned despite challenges related to resource allocation. The customer's previous attempt at machine qualification faced delays, prompting them to seek Körber's expertise. The approach implements a single-test method based on the ASTM E2500 model, which minimizes redundant testing and leverages Good Engineering Practices to ensure efficient verification of machine functionality. The project team focused on critical risk assessments and streamlined processes to manage and mitigate potential issues effectively. By maintaining close cooperation with Körber's consulting experts, the customer benefited from a tailored solution that significantly reduced time-to-market and enhanced operational efficiency. The successful implementation of this unique methodology has established a new standard for machine qualification in the industry.