A risk-based approach is followed for establishing an effective cleaning validation, including the development of policies, master plans and the appropriate content for each study to be performed incorporating critical quality attributes and critical process parameters and process control.
Vastek Inc provides consulting services in the following areas.
– Cleaning Validation Regulatory Guidelines
– Cleaning Validation Methodology
– Worst Case Product Selection Matrix
– Analytical Development
– Visual Examination – Sampling, Swab Sampling, Rinse Sampling
– Analytical Testing and Reporting
– Cleaning Validation Sampling and Testing
– Qualification and Validation