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Comparability Studies & Process Changes
How can it be ensured that process changes do not pose any quality risks?
Online meetup or at your company
Service Description
Changes to processes, materials or sites require proof of comparability – often under significant time pressure. Approach Statistically sound comparability studies enable the quantitative assessment of changes and their impact on critical quality attributes. Outcome Structured comparability strategies Statistical evaluation of process changes Support with regulatory justification Added value Faster implementation of process changes Reduced regulatory uncertainty Support with lifecycle management in accordance with ICH Q12 Lifecycle Management
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