We plan your validations and carry them out for you.
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We carry out process validations for your production. We create the planning and risk analysis. This gives you a clean basis for later process changes or improvements.
We prepare risk analysis, validation plan and report for you according to your SOPs.
More power together Fast, cleanly documented process validations
We carry out the risk analysis for you and also draw on process data and laboratory data.
In this way, we work out critical parameters and possible intervention limits for the process for you.
Validation plan and parameters
We carefully examine the critical process parameters in particular and thus determine the suitable parameter constellation for the process validations.
Implementation and conclusion
All process parameters are critically checked within the validation. You thus gain a robust process design and cleanly documented validations.
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Process validation Definition of the "EMA
It is a science and risk-based real-time approach to verify and demonstrate that a process that operates within the predefined specified parameters consistently produces material which meets all its critical quality attributes (CQAs) and control strategy requirements.