SUPAC- Post Approval Changes suggested by FDA to Industry

Scale-up, process validation, and technology transfer are conducted at the late phase of product development. However, the performance of these steps is largely dependent on the product composition and process selected in the early phase of development. The technology chosen at an early developmental stage and employed in manufacturing the bio-batch stays with it during its life. During this early phase, the development scientist must consider the future demand of the product in selecting the process and equipment. In reviewing a manufacturing process, it is important to consider the physico- chemical properties of the drug and excipients along with equipment capabilities and limitations. Involvement of production personnel in the manufacturing of a batch prior to the bio-batch often helps in the develop- ment of a robust process. All equipment should be quali¢ed for installation, operation, and performance prior to the bio-batch. The equipment should be cleaned and tested as per a cleaning validation protocol. The bio-batch should be evaluated for process performance as per a process validation protocol. All operational documents and test results generated from the bio-batch must be reviewed prior to initiating further scale-up and=or technology transfer. A team effort among formulation, validation, production, analytical, and logistic support groups is crucial to the success of scale-up and technology transfer.