投诉与撤回s14033幻灯片.pptVIP

World Health Organization * * Critical defects are those defects which can be life-threatening and which require the company to take immediate action by all reasonable means, as soon as the defect becomes apparent, whether in or out of business hours. This means that all wholesalers must be alerted and the necessary actions taken to commence recalling the product throughout the distribution chain. This illustrates how important distribution records are, including those of the wholesaler. Examples of critical defects are: Product labelled with incorrect name Counterfeit or deliberately tampered with product Microbiological contamination of a sterile product. It can be seen from the examples that it is critical to patient health that immediate action is taken. It may mean using radio and television news broadcasts to conduct the recall. World Health Organization * * Major defects are those defects which may put the patient at some risk but which are not life-threatening. They will require the recall of the batch or product withdrawal within a few days. In some countries this is specified as within 48 hours. Examples of major defects are: Any labelling/leaflet misinformation (or lack of information) which represents a significant hazard to the patient Microbial contamination of non-sterile products with some risks Non-compliance to specifications (e.g. active ingredient assay close to limits but out of specification). A country may decide on different time-scales for recalls, depending on the appropriate response for the product or defect concerned. World Health Organization * * Other defects are those defects which present only a minor risk to the patient. Any batch recall or product withdrawal would normally be initiated within a few days. In some countries this is specified as within five working days. Examples of such defect are: Readily visible isolated packaging/closure faults Contamination which may cause spoilage or dirt and where there is minimal