| The pharmaceutical industry has been reluctant to introduce change into its manufacturing processes because of perceived regulatory complications. From a manufacturer's perspective, there are several differences in the country-specific regulatory regulations. Additionally, any process-related changes are managed by time-consuming regulatory submissions. Thus, there have been few initiatives encouraging implementation of innovative pharmaceutical development, manufacturing, and quality assurance.;The benefit of implementing harmonized ICH guidelines throughout the different stages of a product life cycle will give a clear advantage for a less restrictive regulatory submission based on scientific knowledge and process understanding. This thesis discusses future opportunities for ICH Quality topics to mature overall quality systems to improve manufacturing cost and the quality of pharmaceutical products.;ICH guidelines Q8, Q9, and Q10 are cornerstones of the new ICH quality vision of creating a regulatory framework based on a harmonized pharmaceutical quality system across three ICH regions: USA, Europe, and Japan. |
