09
Dec

Corrective and Preventative Action – or CAPA. Sometimes the mere mention of this can send pharmaceutical companies and their staff into panic mode, especially if it comes on the heels of a 483 warning letter.

With everyone scrambling to evaluate how quality issues – whether in the lab or as part of the manufacturing process – can be addressed, they tend to hit the panic button. Rushed decisions ensue, and then teams are scrambling to find alternate methods of meeting FDA requirements in a shortened timeframe.

But it doesn’t have to be this way.

Read More...