Developing a process validation strategy early in clinical development is critical for a successful validation program, including timeline, cost, and resource requirements.
RCM provides the expertise to collect data, evaluate your manufacturing process, and develop your validation strategy from the design stage through commercial production.
The Process Validation program will follow the three stages recommended by the latest FDA Guidelines, covering the entire lifecycle of a product.
Stage 1: Process Design
Stage 2: Process Validation or Process Qualification
Stage 3: Continued Process Validation/Verification
See Case Study: HERE
