/Tag: CAPA

10 Reasons Why the Deviation Investigation System Fails

For some companies, manufacturing is a crapshoot. There is little basis for confidence that that the right equipment, materials, components, people and records will be at the right place and the right time to begin manufacturing. And once manufacturing starts, a crystal ball is as good as anything to divine whether the product batch will be released on schedule. [...]

By |2016-07-08T14:18:34-05:00February 24th, 2011|CGMP, cGMP Quality Assurance and FDA 483s, FDA, quality assurance|