Process Characterization & Validation

Process characterization is part of a systematic approach to validating control ranges of parameters related to the production process. Effective process validation significantly contributes to assuring drug quality. It is crucial to prove that varying process conditions result in consistent Quality based on a carefully defined set of specifications.

Risk management system and Quality by design are the guiding principles following the whole lifecycle of the product. They are the fundamental basis for process characterization and validation activities performed by us.

Firstly, we perform a risk assessment to guide subsequent activities, clearly defining which parameters must be investigated. Critical Quality Attributes (CQAs) are linked to clinical safety and efficacy data and critical process parameters (CPP).

We then perform a scale-down model of the process while varying the parameters defined as potential CPPs. The control strategy defined for the process are tested to evaluate the criticality of each parameter for their impact in the CQAs.

We perform an intermediate stability study to provide documented evidence that a selected number of process intermediates can be stored for a pre-determined hold time. We also assess the stability of media, feeds and buffers.

Ultimately, we reassess CPPs based on process characterization studies. The process’s Normal Operating Range (NOR) is positioned within the Proven Acceptable Range (PAR) for each CPP defined during the Process Characterization.

For process validation activities, we assess process information, identify areas of remaining risk and prepare validation protocols. The validation runs are then executed at the set points of the process operating parameters.

Rely on our extensive expertise and experience in effective Process Characterization and Validation services to accelerate your projects seamlessly.