1.What are critical, major and minor defects of a product ?
Critical defect : Critical defect are those defect which can be life-threating & which require the company to take immediate action by all responsible means as soon as the defect becomes apart whether in or out of business hours.
Example : 1. Products labeled with incorrect name.
2. Counterfeit or deliberately tampered with product/
3. Microbiological contamination of a sterile product
Major defect : Major defect are those defects which may put the patient at some risk but. Which are not life-threating
Example : 1. Any labeling/leaflet misinformation which represents a significant hazard to the patient
2. Microbial contamination of non-sterile product with some risks.
Minor defect: Minor defect are those defects which present only a minor risk to the patient. Any batch recall or product withdrawal would normally be initiated a few days.
Example: 1. Readily visible isolated packing faults
2. Contamination which may cause spoilage or dirt & where there is minimal risk to the patient
