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Distribution records shall contain the name and strength of the product and description of the dosage form
to ensure the quality
and signed
EP or equivalent
quality and purity
9.5 - Records and Reports - Complaints Files distribution Distribution records shall contain theQuality Control must review all complaints to determine the potential failure of a drug product to meet any of its specifications and whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to competent authorities in the country where it is marketed
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