Formulation Technology was hit with a 483 when inspectors found that testing and release of drugs made there didn’t include “appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.”
The FDA is increasingly impatient with manufacturers who skip steps or cut corners in the final steps of the quality control process. Check and recheck as you may, if you batch is released without final testing your inspector won’t be pleased.
Generally speaking, our experts say, it’s better to be conservative at this point.
On the other hand, that doesn’t just mean rejecting batches left and right, either.
That isn’t a good sign either. “If you’re rejecting a lot of batches, it puts your whole product into question,” notes a former inspector. “After all, you’re just sampling batches anyway, so if you have to reject too many, who knows what other problems you’re having with your process.”
Ultimately, it’s all about having good processes in place, of course. If your manufacturing processes are out of whack, it’s much better to clean that up before your products are ready to ship. Too many companies, however, try to cover up QA slips at the last possible minute.
And if the inspector catches a quality control problem at this stage, they’re going to question the entire QA process, an ex-FDA leader says. “Their position is that
QA should have caught the problem earlier, while things were in process,” he says.
Firms that release questionable products get slapped with two 483s, one for the GMP failure and one for poor QA. It can only get worse from there.