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Methods requiring validation must be added to the VMP
SOP and report form for the disintegration testing of tablets and capsules according to the method
13 and to limits specified in USP <1111> and EP 5
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
USP 741 Melting Point haccp Methods requiring validation must beSOP 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