An “It’s Approved, Don’t Improve It” Mentality

This week, I will address the fourth of nine common CGMP Quality System shortcomings; an “It’s Approved, Don’t Improve It” Mentality.

I have found that many manufacturers have a resistance to improving their process because of a potential to impact market supply. Although regulatory hurdles associated with significant processing changes could create difficulties, not making changes for this reason can be short-sighted.

Immediately after licensing a product, most manufacturers shift their focus from gaining product approval to increasing market demand. Once successful, they often experience manufacturing capacity limitations due to their initial efforts to minimize capital start-up costs.

With an emphasis on increasing market demand and manufacturing capacity, proactive and continual product / process improvements are often minimized. When this focus shift is combined with limited initial product/process characterization, product quality can be put at risk.

It has been said that “the process is the product.” A sub-robust process can create significant issues for the most rigorous Quality System. When processing methods, techniques, and materials are not sound, then manufacturing difficulties are bound to surface. Likewise, if the product is sensitive (i.e., susceptible to oxidation), then a robust process becomes essential to assuring product quality.

To overcome this shortcoming, the Quality Unit should not lose sight of the importance of continually evaluating the product and process to achieve a better understanding and to increase the processes' robustness.