9.5 - Records and Reports - Complaints Files distribution

9.5 - Records and Reports - Complaints Files distributionQuality 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

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

to ensure the quality

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

quality and purity

You must provide hand-washing facilities that are designed to ensure that an employee's hands are not a source of contamination of components

water supplies

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

Handy discount pack at 20% off the normal price of 24 of the most commonly used USP / EP test methods and report forms covering solid dose forms

and signed

EP or equivalent