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Introduction, Concepts and Regulatory Philosophy, Mix up, Routes for Cross…
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Mix up
Human error
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Local environment (lights, noise, and heat)
Operator workload (too busy, bored)
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Local culture, e.g., is procedural innovation discouraged?
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Ease of error, e.g., a function of design, can an error be made and how easily?
example
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Unintended transfer of materials or product from one vessel to another containing different product/materials
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