Fast Process Characterization & Process Validation Service

BLA readiness in 14 months

Boost your product with accelerated approval pathways

Process characterization (PC) refers to establishing a strategy of process control by purposely varying operational parameters to determine their effect on product quality attributes and process performance. PC normally starts in late Phase II or early Phase III.

The purposes of PC includes identification of critical process parameters (CPP) that impact critical quality attribute (CQA), determination of manufacturing operating ranges and acceptance criteria, and determination of interactions between process parameters and critical quality attributes.

Process validation (PV) refers to evaluating the process design to determine if it is capable of reproducible commercial manufacture, including design of the facility and qualification of the equipment and utilities & process performance qualification (PPQ).

The purposes of PV includes validation of process, identification of critical process parameters based on risk assessment, and Implementation of the proven control strategy .