Title: Importance of quality control in pharmaceutical manufacturing

Abstract
Quality control plays a critical role in the pharmaceutical manufacturing industry to ensure that
medicines are safe, effective, and of high quality. The main objective of quality control is to
ensure that pharmaceutical products meet the required specifications and standards throughout
their production, from raw material sourcing to the final product release. Pharmaceutical
companies must comply with strict regulatory requirements and guidelines, such as Good
Manufacturing Practices (GMP), which aim to ensure that the products are consistently produced
and controlled to meet the quality standards appropriate for their intended use. Quality control
includes a range of activities, including testing of raw materials, in-process controls, finished
product testing, and stability studies, among others. This review gives insights on role of quality
control followed by the current and upcoming changes in the pharmaceutical manufacturing in
terms of quality control
Keywords: CGMP, GMP, Pharmaceutical manufacturing, Pharmacovigilance, Quality control
Introduction
Pharmaceutical manufacturing requires strict quality control to ensure that each batch of
medicine is safe, effective, and consistently meets quality standards (Sardella et al., 2021).
Quality control involves ensuring standards and procedures are being met, which may include
conformance testing as well as feeding information back into the initial system and examination
phases. It is important to apply quality management throughout the entire manufacturing process
to ensure that the final product is of high quality. The Current Good Manufacturing Practices
(CGMPs) regulation is the main regulatory standard for ensuring pharmaceutical quality
(Covarrubias et al., 2022). The World Health Organization (WHO) also emphasizes the
importance of implementing Good Manufacturing Practice (GMP) to ensure that products are
consistently produced and controlled according to quality standards. GMP helps boost
pharmaceutical export opportunities and prevents the circulation of poor-quality medicines that
can damage health (Gouveia et al., 2015).
The global active pharmaceutical ingredient (API) market is predicted to expand at a compound
annual growth rate (CAGR) of 6.3% from 2016 to 2021, reaching $213.97 billion in 2021. This
growth underscores the importance of effective quality control practices in the pharmaceutical
manufacturing industry. Since, quality control is a crucial aspect of pharmaceutical
manufacturing that ensures the safety and efficacy of drugs, the FDA has established the Office
of Pharmaceutical Quality (OPQ) to implement a uniform drug quality program across all sites of
manufacture, whether domestic or foreign, and across all human drug products (Thind et al.,
2020). Additionally, the FDA enforces Current Good Manufacturing Practice (CGMP)
regulations, which outline the minimum requirements for the methods, facilities, and controls
used in manufacturing, processing, and packaging of drugs. International Organization for
Standardization (ISO) play significant role in the understanding and application of the guidelines
and technical requirements for registration of pharmaceutical products and this organization is
the only initiative that brings together the drug regulatory authorities and the pharmaceutical
industry in Europe, Japan and the United States (Gouveia et al.,2015).
According to a research-survey conducted in Japan it was found that there is lack of education in
quality control and assurance field which is a major shortcoming because these are superlatively
imperative in pharmaceutical industry (Komatsu et al., 2021). Pharmaceutical companies must
consider every aspect of quality control, from verifying the quality of the raw materials going
into the process, the production steps that may change the makeup of those materials, and
ensuring that standard operating procedures have been followed in every step until the final
product ships out. Current Good Manufacturing Practice (CGMP) Regulations are the primary
regulatory standard for ensuring quality control in pharmaceutical manufacturing and they set
requirements for quality control in manufacturing processes and facilities to prevent
contamination, errors, and other issues that could impact product quality. These regulations are
enforced by the Food and Drug Administration (FDA) and ensure that manufacturers have
comprehensive and up-to-date knowledge of their products to guarantee safety and efficacy.
Pharmaceutical companies are also increasingly embracing digitization, automation, and online
testing to enhance their quality control processes.
Significance of Pharmacovigilance
Recently there is an increase in cases of poorly-insoluble pharmaceutical products which is a
major concern and quality control is being implemented to solve this issue (Peltonen, 2018). The
collection and assessment of individual case safety reports (ICSRs) is important to detect
unknown adverse drug reactions particularly in the first decade after approval of new chemical
entities (Trippe et al., 2017). The various phases of the drug manufacturing and distribution of
pharmaceutical products require inputs from pharmacovigilance to assess any effects of quality-
related issues and to identify proportionate risk minimization measures that often have design
implications for a medicine which requires a close link between proactive vigilance and good
manufacturing practice. Nevertheless, even older medicines, such as generic drugs, can generate
new risks (Gallelli et al., 2013). For these drugs a change in the safety profile could be the result
of inadequate control of their quality, manufacturing and distribution systems. To overcome such
an obstacle, it is necessary to fully integrate manufacturing and pharmacovigilance quality
systems in the medicine life-cycle. Pharmacovigilance activities should indeed be included in all
phases of the drugs' manufacturing and distribution process, regardless of their chemical
complexity to detect quality-related matters in good time and reduce the risk of safety concerns
to a minimum (Hamid et al., 2022). Drug manufacturing process was impacted due to pandemic
and the necessity to develop vaccines faster played a lead role.
Changes for Quality control in pharma industry after Covid-19 Pandemic
Quality control is a vital aspect of the pharmaceutical industry, and the COVID-19 pandemic has
brought new challenges to quality control operations such as social distancing requirements and
restrictions on having analysts present on site (Vallatos et al., 2021; Covarrubias et al., 2022).
Bioinformatics is one area that can help improve quality control in the pharmaceutical industry.
The use of bioinformatics in quality control highlights the importance of comprehensive
reporting, effective communication, and promoting effective collaboration (Xia et al., 2017). The
FDA provides guidance for the analysis of nucleic acid next-generation sequencing (NGS) data
using bioinformatics, which can be used with the analytical techniques to process this data. A
bioinformatics tool named “Breeze” was designed by European researchers (Potdar et al., 2020).
This application provides a complete solution for data quality assessment, dose-response curve
fitting and quantification of the drug responses along with interactive visualization of the results
and thereby making the quality control process tranquil. Furthermore, in the next five to ten
years, new technologies that characterize Industry 4.0, such as connectivity, advanced analytics,
robotics, and automation, have the potential to revolutionize every element of pharmaceutical
quality control labs (Hole et al., 2021).
Conclusion
Quality control has significant importance in pharmaceutical manufacturing process. Quality
control not only supports to maintain efficacy and safety of pharma products but also helps in
standardization of manufacturing process. Regulatory bodies and organizations including FDA,
WHO and ISO controls the GMP involved in manufacturing of various pharmaceutical products.
Currently, pharma industries are shifting towards using high throughput data analysis and
bioinformatical approaches in drug development to reduce time and achieve high efficiency with
controlled methods and safety regulation.
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