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.

ANNEX 15 EU GMPs Deadline : 1 October 2015

 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.