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(a) Created procedures shall be established and followed prescribing a system for reprocessing batches that don't conform to expectations or specifications plus the ways being taken to insure that the reprocessed batches will conform with all founded expectations, specifications, and features.23. Does FDA think about ophthalmic drug products1 for b

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. It could also be Employed in other purposes, which do not have particulate issue specifications, exactly where bulk H2o for Injection or Purified Drinking water is indicated but exactly where usage of a validated water method just isn't useful or where by relatively greater portions than are offered as Sterile H2o for Injection are necessary. Ste

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