The inspector checks the raw material container has a “hold” or quarantine sticker pasted by a warehouse personnel to indicate if the material is subjected for acceptance or rejection.
Samples are submitted to the laboratory for testing.
The sample is subjected to tests such as:
physical and organoleptic examination
identification tests
limits of impurities
potency or assay
microbiological tets
If the raw materials meet with monograph specifications it is “approved” for used. Otherwise it is rejected.
Decision stickers (approved or reject) are issued by the QC department. The decision sticker is placed on the top of the quarantine sticker.
Materials will then be sending to either rejected or approved areas.