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Review Papers | Pharmacy | India | Volume 12 Issue 11, November 2023
Wide Concept of Quality Assurance
Jayesh Ranjit Patil
Abstract: Quality assurance (QA) is the integral segment of quality management devoted to ensuring confidence in the performance of quality. This assurance extends both internally to management and externally to clients, government agencies, regulators, certification bodies, and third parties. An alternative definition characterizes QA as the comprehensive execution of targeted and organized activities within a quality framework, documented to provide assurance that the product or service will meet the required quality. QA is all-encompassing and is not contingent on the specific requirements of the product being developed. Quality assurance (QA), quality control (QC), and good manufacturing practice (GMP) are critical considerations in the manufacturing, distribution, and marketing of pharmaceutical products, ensuring their identification, potency, purity, pharmacological safety, and efficacy. These terms are defined in various international regulatory documents, including those from the WHO, USFDA, MHRA, TGA, MCC, etc. The quality of a pharmaceutical manufacturer's products hinges on the level of adoption of QA, QC, and GMP systems throughout the production, distribution, and marketing processes over their total shelf life. The main objective of this article is to elucidate the fundamental differences between quality assurance, quality control, and good manufacturing practice (GMP), emphasizing their indispensability for pharmaceutical products. This overview delves into quality by design, identifying its elements and outlining process parameters and quality attributes for each unit operation. The advantages, opportunities, and steps involved in Quality by Design for pharmaceutical products are discussed, based on ICH guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems. Additionally, the article highlights the application of Quality by Design in pharmaceutical drug development and manufacturing. This article will centre its attention on certain aspects of pharmaceutical quality systems concerning the quality assurance (QA) of produced medications. As previously noted, the eight pillars forming the basis of PQS provide a solid groundwork for further exploration.
Keywords: Quality assurance, quality control, good manufacturing practice, good laboratory practice, quality risk management
Edition: Volume 12 Issue 11, November 2023,
Pages: 1853 - 1857