ABSTRACT
Generic product development aims at the formulation of a product bioequivalent and=or pharmaceutically equivalent to a speci¢c reference product. The product should be manufacturable and the manufacturing process must be validatable. The formulation and manufacturing process developed by scientists at a pilot scale must be capable of manufacturing large scale production batches. Scale-up and technology transfer are crucial steps in pharmaceutical product development process. During this stage, process validation activities establish the robustness and limitation of the manufacturing process and assure that the product consistently meets predetermined quality attributes.Critical process steps and product properties are thoroughly examined as per a validation protocol. The process is scaled up to a batch size close to the bio-batch or production batch after the initial development work. Experimental design may be employed to study and optimize critical parameters.Depending on the complexity of manufacturing processes involved, such as dry blending, wet granulation, roller
compacting, tableting, encapsulation, coating, etc., appropriate process parameters are carefully monitored and viable ranges established. The process may be further validated at the extremes of these ranges to set up controls for the manufacturing process.
