9.5 - Records and Reports - Complaints Files distribution Distribution records shall contain the

Distribution records shall contain the name and strength of the product and description of the dosage form

EP or equivalent

Such reviews should normally be conducted and documented annually

SOP and report form for the measurement of Conductivity by Quality Control using a pH meter and conductivity electrode according to USP <645> and EP 2

to ensure that it functions in accordance with its intended use

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