Are Your Smoke Studies Sufficient?

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Smoke studies or air flow visualization studies are used in aseptic processing facilities to confirm […]

Is your data reviewer reviewing your “real” data?

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Verification of lab data is outlined is CFR section 21 CFR 211.194(a)(8) which states: “The […]

Are your analytical test methods written properly?

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For each drug product, there should be a laboratory determination that the product meets final […]