**Abstract**

Mass production was part of the industrial revolution in 1870 and, with it, a huge step change in manufacturing processes. Its impact was ground breaking and became even more remarkable with automation in a business production environment. The chemical industry is one of the manufacturing sectors that has benefited from the technology of mass production achieved through automating the business process. In this era of industry 4.0 and with the associated advanced technologies of smart manufacturing, cloud computing, cyber physical systems and internet of things, mass production has been revolutionised but still faced issues such as quality control of the production process which was affected by supply chain management, customised production of commodity and specialty chemicals and huge demand from other chemical industry manufacturers. This chapter has reviewed the evolution of mass production during traditional manufacturing to the present day and carried out a risk assessment to quality of production in a mass production environment with a view to recommending adequate quality control of the production process. The chapter also included a case study for mass production of a pharmaceutical drug—Amoxicillin which was partly batch produced into dry powder and then mass produced using tableting and encapsulating machine, highlighting sources of contamination and inconsistency in tablet weight if adequate control measures were not put in place.

**Keywords:** mass production, quality control, chemical industry, risk assessment, manufacturing, tableting/encapsulating
