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The investigation shall extend to other batches of the identical drug solution along with other drug products that could are already connected with the particular failure or discrepancy. A created history from the investigation shall be produced and shall include things like the conclusions and followup.(b) Valid in-procedure technical specs for th
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- A complete list of raw resources and intermediates designated by names or codes sufficiently certain to recognize any special excellent properties;· Paperwork should not be hand prepared .In which paperwork call for the entry really should be crystal clear, legible and indelible. Sufficient Area ought to be deli
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