Avoiding FDA 483s Strategy #4: Make sure written procedures for testing are rock-solid—and follow them

Wyeth was dinged by inspectors when it failed to follow its own written procedures for sampling and testing—specifically failing to test at the beginning, middle and end of manufacture for its ChapStick Medicated Stick. It also got cited for failing to follow its own procedures for handling consumer complaints.

It’s hard to tell which upsets FDA inspectors more, a lack of procedures for ensuring cGMP or a clear failure to follow them. Either way, failures to establish and stick like glue to testing procedures generated a bunch of FDA 483s last year. The FDA inspectors get very nervous when actual operations don’t match procedures, our panel said.

The thing is, you can’t necessarily fix the problem by imposing tougher discipline or giving employees more training. In some cases, a procedure may just be broken, suggests one consultant.

“The company’s got to make sure that procedures are workable,” he says.

“Sometimes, procedures start out as a comedy of errors, and even when people try to fix them, they’re still undoable.”

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

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