A comprehensive approach
Nitto Avecia has established a Validation Master Plan across its sites to define strategies and requirements necessary to achieve and maintain validation. The plan addresses validation of facilities, utilities, equipment, analytical methods, processes, cleaning, computer systems, and automated systems.
Validation/PPQ of manufacturing processes
We use small-scale models to characterize the manufacturing process and provide data to justify key process parameters. These characterization activities rely on Design of Experiments (DoE) as a structured approach to experimentation, minimizing risk during the manufacture of PPQ batches. Our Process Development Validation team has extensive experience with the design and execution of PPQ activities, from the Validation Master Plan, through PPQ batch execution, to the validation summary report, which documents the process as validated and ready for commercial production.
Validation of analytical methods
Nitto Avecia uses a phase-appropriate approach to qualification and validation of analytical methods. For early-phase projects, methods are qualified to assess specificity and other key performance indicators such as accuracy, precision, and robustness. For later-phase projects, methods are validated in accordance with ICH Q2(R1). Validation work is performed by our Analytical Development and Quality Control Groups.
Dedicated project management
Our project managers are customer focused and report directly to the VP of Business Development and Project Management. All project managers have technical backgrounds, and together they have more than a century of combined industrial experience at Nitto Avecia.