**3.2 Risk assessment of quality assurance and control during mass production of chemicals**

**Table 2** shows potential risk variables associated with quality control during mass production. It ranges from issues associated with acceptance sampling of materials and products at the input/output stage to contamination from tableting machines, impure product and variation in tablet weight.

Tian et al. [21] carried out quality risk assessment and mitigation of pharmaceutical continuous manufacturing of a case study using flowsheet modelling approach (an engineering approach that can provide a framework to understand the impact of process dynamics on drug quality and associated risks during production, thereby facilitating the development of robust continuous processes) and identified a potential area for model improvement. Using sensitivity analyses they identified the significance of process parameters and material attributes on the dynamic responses and quality attributes of the tablet. They also conducted risk analysis using residence time distribution models to identify the impact of flowrate disturbances on product quality. Consequently, they were able to develop risk mitigation strategies to enable continuous production of high quality tablet.


#### **Table 2.**

*Risk assessment of quality control during mass production.*
