Validation / Process Performance Qualification (PPQ)

Ensure clearing to commercial manufacturing

Based on the requirement of consistency and reproducibility in pharmaceutical manufacture, Veliter’s risk-based approach is to use the current guidelines and standards for validation and Process Performance Qualification (PPQ).

A comprehensive approach

Veliter has established a Validation Master Plan across its sites to define strategies and requirements of validation. The on site validation includes as follow:

Facility and Utilities Validation
Equipment Validation
Analytical Method Validation
Process Validation
Cleaning Validation
Computer and Automated Systems Validation

Validation/PPQ of manufacturing processes

Design of Experiments (DoE) as a structured approach will be utilized in small-scale models to characterize the manufacturing process and provide data to justify key process parameters, minimizing risk during the manufacture of PPQ batches. PPQ activities, from Validation Master Plan design to PPQ batch execution will accumulate into validation summary report documenting the process as validated and ready for commercial manufacturing.

Validation of analytical methods

A phase-appropriate approach to qualification and validation of analytical methods is carried out throughout entire program. For early-phase projects, analytical methods are qualified to assess specificity, or 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.

Positive oligo program experience, from end to end

Focusing on your needs and building long-term partnerships, your own Veliter’s project manager will be flexible and responsive. This is Veliter’s approach to make your oligonucleotide program move smoothly through pre-clinical to commercial.