Process Validation
When the process technology is defined and the manufacturing documentation accurately reflects the developed production steps, the process is ready to move into the Validation Stage. BioTechLogic has expertise in managing all phases of process validation, and proven experience in presenting the approach, the results, and the conclusions of a successful validation to global regulatory agencies.
Process Validation consists of three critical phases:
- Process Pre-Qualification
- Manufacturing Qualification
- Life Cycle Qualification
BioTechLogic can design the strategy to complete Process Validation in a timely and compliant manner, and effectively manage all activities related to these three phases.
Example of Our Process Validation Services:
- Pre-Qualification Report: Establishment of Critical Process Parameters and Controls
- Process Validation Protocols and Reports
- Life Cycle Trending Procedures