ABSTRACT
A comprehensive model for the pharmaceutical industry on the procurement of new materials can be found in fragrance and flavour industries. Control of materials has changed and requires attention in order to achieve a robust process model. The purpose of material control in design of process is to identify, characterize and standardize properties that are determined to be critical to consistent end-product performance. The unique chemistry of the local materials, environmental pollutants, increased handling and logistical issues or in-transit temperature variation are some of the factors causing unpredictable variability that can be introduced and can alter material performance characteristics when used in large-scale production. The process design issues to be considered may include additional analysis not described in compendia or special handling to deagglomerate particles prior to use. The final result of an effective material design analysis is robust process control. In summary, quality control and quality assurance sampling must be carefully applied to processes according to the process design.
