Process Validation and Process Capability Projects
Process Validation and Process Capability are more than just regulatory requirements. A validated and capable process demonstrates that it will continue to produce medicinal products that meet the specifications. Secondly, it reduces the overall cost of quality by minimizing wastes due to rejections, and preventing process discrepancies that need to be investigated.
We can help you adequately characterize the process and develop a well defined process validation strategy. Secondly, we can also help improve process controls to further reduce statistical variability.
Lean and Six-Sigma Projects
Lean and Six-Sigma projects are often implemented with little thought to regulatory requirements of planned redundancies and purposeful oversight by the Quality Control Unit, over manufacturing and related activities.
When implemented correctly, however, Lean, and six-sigma project can be well-aligned with the regulatory oversight requirements. We, at GMP Scientific, can help you evaluate all the critical inputs and outputs of the DMAIC process and provide you with appropriate guidance to align your oversight steps.