Technology Transfer and Process Validation
From laboratory to pilot scale, pilot to commercial manufacturing, or from site to site, transferring technology efficiently, economically and safely is the goal. In most cases, a body of knowledge exists for a specific product and the process to manufacture it. Understanding what is critical to the quality attributes of the product, how the process is monitored and controlled, how parameters or unit operations scale and what tolerances there are for input variability, will all be key to transferring a process that is robust.
We collaborate with your development, manufacturing, engineering and quality teams to understand the body of knowledge, technology transfer goals, safety and quality systems. We will help you to formulate and execute a manufacturing scale-up, process control and validation strategy.
Our experience includes:
- Transfer and scale-up gap analysis
- Control matrix design and sampling strategy
- Design space development (uni-variant and multi-variant experiments, DOE)
- Critical Quality Attributes (CQAs) definition (not always the specifications)
- Critical Process Parameters (CPPs) assignment and verification
- ICH Q7, Q8, Q9, Q10, Q11/ Quality by Design (QBD) / Continuous Verification
- Assessment of process capability vs specifications (CpK)
- Process performance qualification
- Validation strategy and life cycle plan