In a recent 483, Baxter was cited for falling short on two exception verifications. This included failing to be sure that lots placed on QA hold had extended to all physical locations relevant to the hold. Baxter also got slapped for failing to be sure that components and containers weren’t withheld from use until the lot was gone over and released by the QA unit.
Every manufacturing process produces some variability in results, but if unless you want the FDA breathing down your neck, you’d better make sure that you’re on top of those variations.
You’ll look even worse if you have a procedure in place, which specifies statistical sampling and validation of performance, but don’t follow your own guidelines. (Not following your own guidelines is a serious faux pas across the board, of course.)
The FDA has always been tough if it finds a lack of good validation procedures, and you can’t always predict what aspect of the process they’ll hone in on during your inspection.
Bear in mind, however, that the FDA has just issued new final guidance on validation.
While that guarantees that inspectors will be paying close attention to following the rules, you can arm yourself by going over the guidance carefully.
”My mantra is that a firm which does exactly the same thing for the foreseeable future will eventually be out of compliance, since they haven’t kept up with cGMP,” says one veteran ex-FDA official who served in a top compliance role.
His advice: go back and look at your validation practices and see how long they’ve been in place. “Practices that passed muster 10 years ago wouldn’t pass today, and that’s where companies get caught,” he warns. “Validation technology has changed a lot.”
If your validation processes haven’t been updated recently, update them promptly. Otherwise, firms will be cited with 483s, and may be written up for severe violations if their practices are very old and ineffective.
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