**Dedication**

*Mass Production Processes*

**of chemicals**

quality tablet.

output materials

react with materials

flow properties

**4. Conclusion**

**Table 2.**

contamination of products.

lently, on the tablet weight.

main-compression force depends on the amount of powder in the die or, equiva-

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

**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

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

This chapter discussed quality control of mass production process in the chemi-

cal industry. It reviewed a typical mass production process, identified current practice in the industry in order to guarantee quality assurance during mass production and finally proposed how this could be implemented in the chemical industry. A combination of acceptance sampling and process analytical techniques were deemed suitable for quality control during both batch and mass production. Quality control during bulk pharmaceutical production was studied where robots and machines were subjected to decontamination quality control procedure. Tableting and encapsulating machines for drug production also needed to be properly calibrated and cleaned to ensure constant tablet weight, and also minimise

**Risk variables Impact from risk negligence**

(4) Change in powder bulk density during compaction (4) Variation in tablet weight

(6) Inaccuracy in the dosing position of the tablet press (6) Variation in tablet weight

(5) Impurities in reactant chemicals (5) Impure product

(2) Inadequate cleaning of manufacturing equipment (2) Contamination of product with impurities

(1) (a) Producer's risk (b) Consumer's risk

(7) Variation in tablet weight

(3) Contamination of product with impurities

machines, impure product and variation in tablet weight.

(1) Use of acceptance sampling to evaluate input and

(3) Chemicals used to decontaminate equipment can

(7) Change in filling efficacy due to changes in powder

*Risk assessment of quality control during mass production.*

**146**

This book chapter is dedicated to my son Kelechi Peter Oduoza who died suddenly during the preparation of this manuscript. May his soul and those of all the faithful departed through the mercy of God rest in perfect peace, Amen.
