9.5 - Records and Reports - Complaints Files distribution Sufficient space should be given

Sufficient space should be given to avoid mix-ups and cross-contamination

Such reviews should normally be conducted and documented annually

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

quality and purity

9.5 - Records and Reports - Complaints Files distribution Sufficient space should be givenQuality 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