Presented by Paul Wlodarczyk at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality.
Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing.
This slide deck explores new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.