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Are regulators looking for disciplinary action against basic GMP errors made by trained and qualified operators?

926 viewsOctober 10, 2022DrugsPharmaceutical
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Sam Smith11.38K January 5, 2021 0 Comments

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Blogolu28.38K Posted January 5, 2021 0 Comments

Q7A does not address disciplinary action against people who make mistakes, nor does it prohibit
you from taking such action if it’s your company’s policy.
You should be very careful of overusing “employee error” or “operator training” as a reason for
failure in lieu of conducting a real investigation. It’s not always the person that’s causing the error.
Sometimes the equipment is set up in a manner that the person can’t do it any other way.
Investigators will raise questions about determining the real root cause if you have too many
deviations where the problem is always seen as operator error. Regulators are looking for root
cause identification and true corrective action, not disciplinary action.

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