The purpose of this SOP is to explain the procedure for operation, calibration, and cleansing with the disintegration apparatus.The revision towards the harmonized conventional for disintegration testing of pharmaceutical dosage forms has been authorized via the Pharmacopeial Dialogue Team (PDG) as explained within the PDG signal-off include sheet.

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Acceptance Test Document implies a document, which defines procedures for testing the operating of put in procedure. The doc will probably be finalized Together with the contractor within just seven times of issuance with the Letter of Award.The scripts must be published by involving the end users who ensure that Every script covers all the mandato

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