9.5 - Records and Reports - Complaints Files distribution Such reviews should normally be

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

EP or equivalent

to ensure that it functions in accordance with its intended use

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

9.5 - Records and Reports - Complaints Files distribution Such reviews should normally beQuality 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