Process Validation

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
  • Hold-time studies
  • Lifetime studies
  • Leachable/extractable assessments
  • Related qualification and validation studies (equipment/facility/utility, cleaning, etc.)
  • Continued process verification and improvement