Process validation is the documented evidence that a process, operated within established parameters (identified during Process Characterization) can perform effectively and reproducible to manufacture a drug substance, intermediate, API, or medicinal product and meets its predetermined specifications and quality attributes in preparation for commercial distribution.
Cytovance® Biologics partners with clients to seamlessly integrate process design, process qualification, and continued process verification data and activities which may include:
Generation of a process validation master plan
Process risk assessments
Process performance qualification batches at the commercial scale
Related qualification and validation studies (equipment/facility/utility, cleaning, etc.)
Continued process verification and improvement