Risk-based qualification and validation of plants and processes
Valicare offers comprehensive support or complete execution and documentation for GMP-compliant qualification and validation projects.
Valicare offers comprehensive services for GMP-compliant qualification of equipment and facilities as well as GMP-compliant validation to ensure the reproducibility of production processes (process validation, PV), cleaning processes (cleaning validation, CV), analytic methods (method validation, AMV) and computer systems (computer system validation, CSV).
Qualification and validation is based on a risk-based approach in order to estimate the effects and deviations on process stability and product quality and furthermore to control time and costs.
Protocols for qualification and validation with defined test methods and acceptance criteria are prepared in accordance with the customer and form the basis for the planned qualification and validation activities.
The reports contain the results of the performed tests and the verification of each acceptance criteria. The reports are created separately for each qualification or validation activity.
The monitoring of changes and deviations and their GMP-compliant documentation and handling completes the Valicare qualification and validation process.