Establishing a CGMP laboratory audit system : a practical guide

In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) re...

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Главный автор: Bliesner, David M.
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Опубликовано: Hoboken, N.J. Wiley-Interscience 2006
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