Formulation stage regulatory requirements

Regulatory requirements in the pharmaceutical industry have created the need for an understanding of this unit operation at an early stage of product formulation, method selection, and process development. Because the process and specifications for the pivotal batches and full-scale production batches must be equivalent, the need for reliable control of the manufacturing process used to produce the test and clinical batches cannot be overemphasized. 

The requirement for sterility in parenteral products is absolute and must be borne in mind at all stages of formulation and process development. The regulatory environment now requires that parenteral products be terminally sterilized unless this is precluded, usually by reason of instability (see the section Manufacturing of Parenteral Products ). 

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