Under Utilized Quality Tools

This week, I will address the fifth of nine common CGMP Quality System shortcomings; under utilized Quality Tools.

Modern Quality tools, such as SPC and PAT, can be very beneficial in establishing an effective Quality System. Ironically, many of the quality tools necessary to implement a Robust Pharmaceutical Quality System are already part of most Quality Systems. They just tend to be under utilized.

A significant under utilized tool is the Annual Product Review. I have found that most manufacturers complete this regulatory requirement simply to complete it, as opposed to completing it to gain product/process characterization knowledge. Most of the APRs I have read go something like this, “we produced “X” amount of batches, most batches meet specifications, root causes and corrective actions were completed for those that didn’t, and no negative trends were observed, therefore everything is beautiful and no process improvement is required. What a complete pencil whipping exercise.

Another under utilized tool is qualification/validation studies. These studies are often written to ensure that they pass. The functionality of these studies is to ensure all facilities, equipment, utilities, and/or processes are functioning sufficiently to ensure problems are minimized during commercial manufacturing. As a QA reviewer, I was often frustrated with change control requests that were submitted to fix problems with equipment or processes that recently passed validation activities. In these cases, validation activities were not completed appropriately.

To overcome this shortcoming, the Quality Unit should maximize the return from their established quality tools by complete more thorough and objective analyses and evaluations.