Systemic analysis of the entire production process
RD&C offers analysis and evaluation of adverse events in manufacturing processes including site visits and audits. Critical process parameters will be discussed; detailed cause studies and risk assessment will result in recommendations for optimization or circumvention of potential issues. Process Analytical Technology (PAT) as well as quality and safety aspects will be considered.
Process deviation management
In case of Out-Of-Specification (OOS) events or process deviations RD&C offers full service for evaluation of causes and implementation of provisions to avoid future issues. The assessment may cover identification of potential impurity sources, cleaning validation, residual impurity levels, suitability of equipment, evaluation of CAPA (Corrective And Preventive Actions) and finally Quality-by-Design (QbD) and Design-of-Experiment (DoE) based process optimization. RD&C strives for immediate response and prompt work on the issue to guarantee maximum time and cost efficiency.