Tag Archive for Audit Report

Re-Audits: When and Why Should You Conduct Them?

Q: What is industry practice — or more importantly, FDA’s viewpoint — regarding re-audits? Do we need defined and documented criteria for when to conduct re-audits? If so, what would such criteria include? A: My experience is that industry rarely does what is…

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CAPA Data: What Can FDA Request to See?

Q: It’s my understanding that during an FDA audit of a pharmaceutical company, the Agency can request to see CAPA data from internal audits — but if you’re a medical device company, it can’t. Is that correct? Also, can the FDA request to see…

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How Often Should You Conduct Internal Audits?

Q: I’ve found conflicting information on how frequently to perform internal audits. The ISO standards and the Quality System Regulation don’t have any frequency recommendations, but FDA’s Quality System Inspection Technique (QSIT) Guide recommends every 12 months. I’ve been in…

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FDA Expectations for Internal Audits

Q: What are FDA’s expectations for internal audits? For example, how frequently should we conduct internal audits? And what documents does FDA expect to see to prove we’re actually doing the audits? A: First of all, FDA expects you to…

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