This week, I will address the seventh of nine common CGMP Quality System shortcomings; Resistance to New Technology.
New technologies can be a blessing or a curse. New technology has the potential to increase process controls and understanding, which can result in higher efficiencies, yields, and product. Conversely, new technology may also create havoc on established processes if implemented incorrectly or hastily.
New technology is also likely to require heavy regulatory scrutiny, which is a deterrent in of itself.
Therefore, the decision process for implementing new technology must weigh the benefit vs. the costs vs. the risk.
I am sure that we can all agree that every new gizmo should not be employed just because it exists. Likewise, it would be foolish to simply dismiss new technology because the burden of implementation and regulatory approval is significant.
To overcome this shortcoming, the Quality Units should explore the possibility of employing new promising technology, but should also considered all possible quality / regulatory ramifications and thoroughly test the technology before implementing it into commercial manufacturing.
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