what are the components needed for a quality system for a ph

what are the components needed for a quality system for a pharamaceutical drug that was recalled for a high level of toxic material in it

Solution

The quality system should have proper storage for the released drug product containers, closures and labeling. The system should have efficient control and laboratory operations such as temperature and humidity control, controlling of pressure variance, should provide pressure cascade. If there is any leakage of drug material, it should have optical device for detection. A proper system for disposal of unwanted substance is a must. There should be proper sanitation and system for cleaning and disinfecting room and equipments.