Ongoing process verification should be conducted under an approved protocol or equivalent documents and a corresponding report should be prepared to document the results obtained. Statistical tools should be used, where appropriate, to support any conclusions with regard to the variability and capability of a given process and ensure a state of control.
Validation and continuous process verification.
-Supporting life-cycle activities: design, qualification and on-going verification.
-Deployment of risk analysis tools and methods for process validation. Our consultants act as facilitators and provide RA tools for the multidisciplinary team.
-Process validation documentation: Validation Master Plan, Process Validation Protocols and Reports. We have experience in oral solid forms, aseptic-sterile, biologics and cellular therapies.
-Update to new process validation guidances and ANNEX 15 EU GMPs: general procedures, design, qualification and “on-going verification” protocols and reports.
Process state of control assessment and statistical advice.
Critical variables to monitor.
Exploratory Data Analysis: Data Mining.
Statistical Process Control : SPC uni & multivariate.
Root cause analysis and troubleshooting.
-Consulting and advice on “Process Knowledge” deployment.