ABSTRACT

A manufacturing process may involve drying and granulation steps as well as intermediate and final mixing steps. Once a blend has been mixed, it may be transported to another location for screening or tableting (or encapsulation). Sampling can be performed at any of these steps in the manufacturing process. Samples can be taken when the blend is in a mixer, while being discharged from the mixer, when it is in a transport container (e.g., drum), throughout tablet compression or encapsulation, and after film coating (if appropriate). Sampling plans need to be developed at each of these stages.