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All validation batches will be manufactured following the same manufacturing process as detailed in the manufacturing instructions. The validation batches meet all requirements specified in the protocol including all registered release for sale tests. All critical process variables in the manufacturing process (Spray Granulation, Milling, BlendingMilling is the most common form of machining, a material removal process, which can create a variety of features on a part by cutting away the unwanted material. The milling process requires a milling machine, workpiece, fixture, and cutter. The workpiece is a piece of pre-shaped material that is secured to the fixture, which itself is attached .