Formulation stage production batches

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 evolution and optimisation of a formulation is an experimental stage that will be conducted on small batches of the material. For a drug with a tablet weight of 250 mg, test batches would t)rpically be 0.5-1 kg, providing up to 4000 tablets for analysis, performance testing and initial stability studies. Similar scales will be used in the optimisation of the product s packaging. 

Once the stage has been reached at which the product has been developed and the formulation and batch size determined, it is time for validation of the manufacturing process and the cleaning process. By that... 

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