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Computerized systems employed for the manufacture of medicinal solutions also needs to be validated In accordance with the requirements of Annex eleven. The pertinent concepts and direction offered in ICH Q8, Q9, Q10 and Q11 should also be taken under consideration.In the event the effectiveness on the Functioning from the UV light during the purif

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Include and invert the plates, and incubate. On examination, if Not one of the colonies exhibits both a characteristic metallic sheen under mirrored light and a blue-black physical appearance underneath transmitted light, the specimen fulfills the requirements of the test for the absence of Escherichia coli. The presence of Escherichia coli may be

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