Water Systems in FDA Warning Letters

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New Drug Approvals

Among the FDA Warning Letters of the past two years there are every now and then letters citing deficiencies in water systems. On the bottom line the reason for objections is always the same. Read more.

http://www.gmp-compliance.org/enews_4359_Water%20Systems%20in%20FDA%20Warning%20Letters_8398,8427,8428,Z-PEM_n.html

GMP News: Water Systems in FDA Warning Letters

Taking a look at FDA Warning Letters from the past two years, objections with regard to pharmaceutical water systems are rather seldom. However, when there are complaints, it is the more interesting that the reason for these complaints is mostly the same: missing reliability. What the authority means in this case is the proof that the water system is capable of securely and reliably producing water in the required quality – taking into account for example the fluctuations in the feed water. The necessary means for this purpose are the validation of the water system and the establishment of a monitoring system which continuously verifies…

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