High Potent API

The highly toxic properties of HPAPIs, present manufacturing and handling
challenges. Specialized considerations in facility design, equipment,
operation, and process safety are needed to achieve the desired level of
containment of the drug substance or finished-drug product. Facility design,
equipment, engineering controls, and the proper operation of facilities and
equipment are needed to achieve the desired level of containment in HPAPI
manufacturing. Operator safety is also critical and involves the use of
personal protection equipment, related training in handling HPAPIs, and
implementation of safe-handling practices and current good
manufacturing practices (CGMPs) to prevent operator exposure and
contamination