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All over all of these communications, concerns have already been lifted that some interpretations of your element 11 requirements would (one) unnecessarily limit using electronic technological know-how within a method that is definitely inconsistent with FDA's mentioned intent in issuing the rule, (2) appreciably raise the expenditures of complianc

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Reference substances should be prepared in order that they do not eliminate any of their potency. Thus it is necessary to validate which the method will give reputable reference options which have not been deactivated by weighing so minor that an mistake is produced; adsorption onto containers; decomposition by gentle; and decomposition from the so

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