Evolution of quality assurance in pharmaceutical industry

It is brief review of History of Quality control, Timeline of evolution of quality assurance in pharmacy field, GMP guidelines and current trends. Quality assurance is a term used in systematic process of determining whether a product or service meets specified requirements. Quality assurance also involves establishing and maintaining quality management systems to continually improve processes and prevent defects or deviations. Overall, a Quality assurance plays a critical role in safeguarding public health and maintaining the integrity. The main functions are to provide consumer satisfaction. This article reviews the evolution of quality assurance practices within the pharmaceutical sector, tracing the historical development of quality control measures and examining the pivotal shift towards TQM methodologies. Quality management of pharmaceutical products was started with production premises based on the principle of Good Manufacturing Practices (GMP) and Food and Drug Administration (FDA) regulating bodies. And this aspect includes the quality, efficacy and safety of pharmaceuticals, including the sources like (impurities- residual solvents and various inorganic and organic impurities in pharmaceuticals.).And these Quality controls has policy to control many critical points starting from raw materials, in - process check, equipment, production, packaging material, packing of finished goods till dispatch. Key aspects such as regulatory compliance, technological advancements, and cultural shifts within organizations are analyzed to understand the driving forces behind this evolution. Insights from case studies and industry trends provide valuable perspectives on the current landscape of quality assurance in the pharmaceutical industry, offering practical recommendations for optimizing quality processes and ensuring product integrity and patient safety.

Authors

Publication Details

Journal
World Journal of Biology Pharmacy and Health Sciences
Published
2024-11-29
DOI
https://doi.org/10.30574/wjbphs.2024.20.2.0937
Citations
2
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
2.26
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article

Evolution of quality assurance in pharmaceutical industry

Monika Rani, Mandapati Harshitha, A Kavya, Adulapuram Aroon et al.
2 citations
World Journal of Biology Pharmacy and Health Sciences
Pharmaceutical Economics and Policy
2.26
article

Evolution of quality assurance in pharmaceutical industry

Monika Rani, Mandapati Harshitha, A Kavya, Adulapuram Aroon, Nagula Anannya
article en
2 citations

Abstract

It is brief review of History of Quality control, Timeline of evolution of quality assurance in pharmacy field, GMP guidelines and current trends. Quality assurance is a term used in systematic process of determining whether a product or service meets specified requirements. Quality assurance also involves establishing and maintaining quality management systems to continually improve processes and prevent defects or deviations. Overall, a Quality assurance plays a critical role in safeguarding public health and maintaining the integrity. The main functions are to provide consumer satisfaction. This article reviews the evolution of quality assurance practices within the pharmaceutical sector, tracing the historical development of quality control measures and examining the pivotal shift towards TQM methodologies. Quality management of pharmaceutical products was started with production premises based on the principle of Good Manufacturing Practices (GMP) and Food and Drug Administration (FDA) regulating bodies. And this aspect includes the quality, efficacy and safety of pharmaceuticals, including the sources like (impurities- residual solvents and various inorganic and organic impurities in pharmaceuticals.).And these Quality controls has policy to control many critical points starting from raw materials, in - process check, equipment, production, packaging material, packing of finished goods till dispatch. Key aspects such as regulatory compliance, technological advancements, and cultural shifts within organizations are analyzed to understand the driving forces behind this evolution. Insights from case studies and industry trends provide valuable perspectives on the current landscape of quality assurance in the pharmaceutical industry, offering practical recommendations for optimizing quality processes and ensuring product integrity and patient safety.

World Journal of Biology Pharmacy and Health SciencesVol. 20(2)
Openalex Percentile: Top 7%
Pharmaceutical Economics and Policy
2.26
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Evolution of quality assurance in pharmaceutical industry — Monika Rani, Mandapati Harshitha, et al. · World Journal of Biology Pharmacy and Health Sciences (2024) | TGRS Research Map | TGRS