Exploring the Evolution of Quality Control in Pharmaceuticals: What has changed?

Abstract

The pharmaceutical industry plays a crucial role in ensuring the safety and efficacy of medications for patients. Quality control (QC) is a critical component of drug development, manufacturing, and distribution. Over the years, QC practices have evolved, and this paper aims to explore the changes that have occurred. This paper provides an overview of the evolution of QC in the pharmaceutical industry, highlighting the key drivers and milestones that have shaped its development. We start by examining the regulatory landscape, which has been instrumental in shaping QC practices. The paper also discusses the shift from traditional quality control practices, such as batch testing and sampling, to a more proactive and risk-based approach. We highlight the increasing importance of Quality assurance (QA) and total quality management (TQM) and Quality 4.0 in modern QC practices. Finally, the paper concludes by reflecting on the challenges that the pharmaceutical industry faces as it continues to evolve its QC practices. Overall, this paper provides valuable insights into the evolution of QC in the pharmaceutical industry and the challenges that lie ahead.