 |
| Process control and process improvement are important parts of life cycle management. |
by Ronald D. Snee, PhD
Snee Associates, LLC
Much of the literature on quality by design (QbD) has focused on the creation of the “Design Space” (ICH 2009) which is the combination of levels of the critical process parameters that produces in-specification product. Design space creation is critical but a process control strategy is also essential and is an integral part of QbD. Stage 3 of the FDA Process Validation Guidance calls for “Continued Process Verification” (CPV), or continually verifying the process is doing what it is supposed to do throughout the life of the product (FDA 2011, Snee 2015). Also if we are to be effective in using life cycle management to manage the process over time. we must have a process management system in place that integrates both process control and process improvement (Snee and Gardner 2008, Snee 2010b).
The focus on QbD places an even greater emphasis on the quality of pharmaceutical products and manufacturing process performance. Indeed process and product control is a major building block of QbD (Snee 2009). A systematic approach to achieve this objective is described below. Improved manufacturing performance and reduced costs are a natural byproduct of the system.
READ MORE »