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drug product containers
Quality 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
Methods requiring validation must be added to the VMP
13 and to limits specified in USP <1111> and EP 5
when such water contacts components
USP 741 Melting Point haccp drug product containersSOP and report form for the melting point determination of solid and semi solid samples by Quality Control according to USP <741> and EP 2. 2. 14
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