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The document discusses a proposed modify while in the coating method for Dapakan 500mg movie coated tablets from the solvent coating to an aqueous coating. It describes changing from coating with Opadry OIC 7000 to coating with Opadry II.4. Audit obligations: Location and the get the job done should
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) where the Lively ingredient comprises a major part of the pill and in which Charge of excess weight could possibly be presumed for being an adequate Charge of drug material uniformity. Pounds variation will not be an adequate indication of information uniformity where by the drug material comprise