Quality Control in the Pharmaceutical Process
The application of the statistical analysis during the planning stages instead of the end of experimentation, where the search for a correction is most likely, was proposed at the beginning of the twentieth century. The books of Sir Ronald Fisher are considered the pillars of the statistical for science and industrial applications. His theory was focused on a proactive approach in research, which contributes to the construction of a current regulatory framework governing the development of pharmaceutical products (Politis et al., 2017).
The quality pioneer Joseph M. Juran, an American Engineer, developed the concept of Quality by Design (QbD), which is considered the best option for the introduction of quality in the stage of design of a product because the main problems are related to how a product was designed (Yu et al., 2014). According to Juran, the planning of quality into goods and services is possible by following a roadmap where should be established a series of universal steps to carry out correct planning of a product or service (Politis et al., 2017). The definition of QbD is then,
A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management (Bruce & Schlindwein, 2018).
The QbD concept has been adopted by many industries, including those related to health care industries, especially the involved in the manufacture of medical devices. Specifically, the QbD concept was adopted in 2004 when the United States Food and Drug Administration (USFDA) started with the initiative for improving the standards of pharmaceutical manufacturing. The USFDA initiate the culture of quality using a published guide for the industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (CGMP). This culture was focused on critical attributes related to chemistry, manufacturing, and control and their relevance to the safety and effectiveness of drug production (Beg et al., 2019). The quality of a product is a complex process to achieve, it is necessary to consider elements such as the cumulative variability in drug substances, excipients, process, and packing materials (Singh & Beg, 2013). A high-quality drug product is considered a product free of contamination and reliably, which can guarantee to the consumer the therapeutic benefit promised in the label (Yu et al., 2014).