1.2.3.7. Quality by Design As PharmaKonic Ltd uses Quality by Design for process development and extension studies performed in the previous upstream process to maintain process continuity, this concept will be integrated into the production of the quality strategy and quality maintenance system quality. Quality by Design focuses on a risk-based approach to ensuring process and product quality through an in-depth understanding of product characteristics and overall process and product performance. This concept will be achieved by defining the product to be produced and through the identification of the Critical Quality Attributes (CQA) and their potential impact on the process and the final product. Quality by Design system will be shown in the following diagram: Figure 1.1: Quality by Design System adapted from (Huynh-Ba, 2009) Quality by Design concept is created based on process steps included as follows: • Product designed based on consumer requirements • Process design consistently meets critical quality attributes (CQA) of the product • Quality system used to integrate process and product knowledge gathered during development • Full understanding of the potential impact of formulation components and process parameters on product quality • Evaluate and control the causes of process variability • Ensure reliable and consistent quality throughout the process life cycle by monitoring and integrating process improvement.1.3. Quality risk managementQuality risk management has been considered a valuable element of an effective quality system and, once performed, plays a crucial role in assessing and controlling potential risks to the quality of medicines throughout the process of production... halfway through the paper. ..... backbone, within this structure there is an O-linked carbohydrate that does not play a significant role in maintaining bioactivity, three attached N-glycans show great influence on stability, immunogenicity and overall solubility .(Li and d'Anjou, 2009) The amino acid sequence will be analyzed for the correct structure through the use of HPLC to differentiate the 165 amino acids present within Epoetin omicron.3. Isoelectric Point Epoetin omicron has been determined to have an isoelectric point between 3.5 and 5 and will be tested to ensure this using an isoelectric focusing gel. This will establish whether the analyzed sample shows any potential for protein modification such as glycosylation or phosphorylation and after this run the correct isoelectric point will be measured using 2D gel electrophoresis. (Technologies of life, 2014)