Process development comprises the early development at laboratory scale through late development at commercial manufacturing scale. This process development may take up to 10 years and therefore, it is important to archive the gained knowledge in a structural manner. This can be achieved by writing development files which contain a summary of the development work such as development research results, process changes and justifications.
Applying QbD in combination with project management tools can support an efficient process development. An experienced CMC project leader is a must have to be able to achieve drug approval by the regulatory authorities and thereby reduce the “time to market” as much as possible.
Progress-PME employees are very experienced in the process development field. Their expertise varies from performing characterization studies at laboratory scale through the validation of the commercial manufacturing scale under GMP requirements. They have extensive knowledge of relevant process steps such as USP, DSP, final formulation, filling and freeze-drying. In combination with their strong project management skills they can support you to successfully define and subsequently validate your commercial manufacturing process.