6 Process
Validations
We plan your validations and carry them out for you.
MORE Our experts carry out your validations for you. You successfully complete changes.
We carry out process validations for your production. We prepare the planning and risk analysis. This provides you with a sound basis for subsequent process changes or improvements.
We prepare the risk analysis, validation plan and report for you according to your SOPs.
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More power together Fast, cleanly documented process validations
Risk analysis
We carry out the risk analysis for you and also draw on process data and laboratory data.
We work out critical parameters and possible intervention limits for the process for you.
Validation plan and parameters
In particular, we carefully examine the critical process parameters to determine the appropriate parameter constellation for the process validations.
Implementation and conclusion
All process parameters are critically checked during validation. This gives you a robust process design and clearly 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.
