Product Manufacturing

Abstract

Once a manufacturing process has been validated, it moves into routine production. It is important to ensure that this transition goes as smoothly as possible. Many of the basic elements should already have been anticipated during the validation phase. These would include generation of the standard operating procedures and batch records or worksheets, training of staff, and decisions on appropriate testing of the product. The next phase is to use these materials as the basis for starting routine manufacturing. This chapter deals with these preparations in a little more detail.