TABLE I

Defining the Expected Profile of an Ideal Raw Material

Ideal Raw MaterialComments
SafeKnown safety profile
Consistent qualityLot-to-lot consistency throughout its life cycle
Well-characterizedKnown material quality
Well-defined product interactionKnown physico-chemical interactions
Compliant to regulatory requirementsUS, European Union, Japan, other regulatory authorities
Continuous supplyKeeping consistent quality
Supply chain transparencyGet to know the supply chain
Manufacturer/vendor relationshipOpen communication, auditing
Back-up supplierAppropriately qualified