Sangmun Shin
Dong-A University, Republic of Korea
Title: Comparative analysis of Quality by Design (QbD) platforms
Biography
Biography: Sangmun Shin
Abstract
In order to improve the quality of a drug product, International Conference on Harmonization (ICH), United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have suggested a various guidelines and Quality by Design (QbD) platforms. To this end, the main objective of this research is to conduct comparative analyses among those platforms. In addition, this research proposes a new QbD platform and its associated guideline. This proposed QbD platform includes six steps: Quality target product profile (QTPP), critical quality attribute (CQA), risk assessment (RA), design space (DS), control strategy (CS), and life cycle management (LM). In addition, this research also provides a number of statistical design and analysis methods, such as quality function deployment (QFD) for CQA procedure, failure mode and effect analysis (FMEA) for the RA procedure, design of experiment (DoE) and response surface methodology (RSM) for design and operating spaces generation in the DS procedure and robust design optimization methods to reduce process variability. Finally, this research demonstrates possible solutions for existing scale-up problems for commercial pharmaceutical manufacturing processes.