Supporting organisations in gaining value from process understanding C o n t a c t +44(0)1925 607030 enquiries@britest.co.uk www.britest.co.uk Challenge Low out of specification assay results were being generated for a capsule-based pharmaceutical product, with significant cost implications for any batch wrongly rejected. Initial investigations by the analytical team pointed towards the sample preparation process as a source of variability. Approach A Britest study was carried out, to create a shared view of the issue that the team was trying to understand, and then to visualise and troubleshoot the sample preparation regime. The study, which involved all the analysts responsible for carrying out the procedure, broke the process down into fourteen unit operations, enablin

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