Quality Control and Assurance Practices in Modern Pharmaceutical Industry

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nThis is an unedited manuscript accepted for publication and provided as an Article in Press for early access at the author’s request. The article will undergo copyediting, typesetting, and galley proof review before final publication. Please be aware that errors may be identified during production that could affect the content. All legal disclaimers of the journal apply.n

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Year : 2025 [if 2224 equals=””]11/10/2025 at 9:27 PM[/if 2224] | [if 1553 equals=””] Volume : 12 [else] Volume : [/if 1553] | [if 424 equals=”Regular Issue”]Issue : [/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] 03 | Page :

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    Prachi Rajesh Patil, Shweta Vinod Raul, Sunila A Patil,

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  1. Student, Student, Assistant Professor, Department of Pharmaceutical Quality Assurance, P.S.G.V.P Mandal’s College of Pharmacy, Untavad, Department of Pharmaceutical Quality Assurance, P.S.G.V.P Mandal’s College of Pharmacy, Untavad, Department of Pharmaceutical Quality Assurance, P.S.G.V.P Mandal’s College of Pharmacy, Untavad, Maharashtra, Maharashtra, Maharashtra, India, India, India

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nThis brief overview outlines the global techniques for figuring out the prevalence of geotaxis impurities (residual solvents and various inorganic and organic impurities) in medications. It is now necessary to reveal a pharmaceutical product’s purity and impurity profiles due to both national and international regulations. These elements are discussed, together with the kinds of impurities, their origins, their control, and regulatory issues, as well as the significance of pharmaceutical quality, efficacy, and safety. The availability of high-quality important pharmaceuticals is a must for the supply of any country’s healthcare system, as inferior medications have the potential to injure or even kill consumers. A medication’s safety and efficacy may be impacted by the presence of unwanted chemicals, even in very small concentrations. Unlike products in other industries, pharmaceuticals are dynamic, and both during production and after final consumption, their color, consistency, weight, and even chemical identity can change. As a result, pharmaceutical quality has long been a global concern and is currently gaining significant attention from regulatory bodies. Pharmaceutical product impurities are a major concern because of the potential harm they may do to medicine stability and shelf life in addition to the intrinsic toxicity of some contaminants. In pharmaceutical and drug products, impurities are harmful chemicals (natural, inorganic, and residual solvents) that can be introduced or created during formulation, aging, or retention with the active pharmaceutical ingredients (APIs). The most prevalent impurities in all APIs are organic ones, which, even with appropriate handling, are naturally incorporated during the multi-step synthesis process.nn

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Keywords: Practical consideration in developing QA/QC system, Element of QA & QC, Inventory Agency, QA/QC Plans, QA procedure, Q. Assurance, Review process, Methodology.

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nPrachi Rajesh Patil, Shweta Vinod Raul, Sunila A Patil. [if 2584 equals=”][226 wpautop=0 striphtml=1][else]Quality Control and Assurance Practices in Modern Pharmaceutical Industry[/if 2584]. Research & Reviews: A Journal of Drug Formulation, Development and Production. 11/10/2025; 12(03):-.

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nPrachi Rajesh Patil, Shweta Vinod Raul, Sunila A Patil. [if 2584 equals=”][226 striphtml=1][else]Quality Control and Assurance Practices in Modern Pharmaceutical Industry[/if 2584]. Research & Reviews: A Journal of Drug Formulation, Development and Production. 11/10/2025; 12(03):-. Available from: https://journals.stmjournals.com/rrjodfdp/article=11/10/2025/view=0

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  1. Intergovernmental Panel on Climate Change (IPCC) (1997). Revised 1996 IPCC Guidelines for National Greenhouse Gas Inventories: Volumes 1, 2 and 3. J.T. Houghton et al., IPCC/OECD/IEA, Paris, France.
  2. Handbook of International Auditing, Assurance, and Ethics Pronouncements, International Federation of Accountants, March 2008
  3. Rodionova, O. Y., Sokovikov, Y. V., & Pomerantsev, A. L. Quality control of packed raw materials in pharmaceutical industry. analytica chimica acta, 2009; 642(1): 222-227.
  4. Quality Assurance in Financial Auditing, A Handbook, IDI-ASOSAI, 2009
  5.  Handbook on Quality Assurance in Performance Auditing, IDI-ASOSAI, 2011
  6.  International Organization for Standardization (ISO) (1994). Air Quality, Determination of Performance Characteristics of Measurement Methods. ISO 9196:1994. ISO, Geneva, Switzerland
  7. Quality Assurance Handbook, IDI-AFROSAI-E, 2007
  8. Feigenbaum, Armand V (1956). “Total Quality Control”; Harvard Business Review. 34(6):93–101.
  9. https://www.firsttimequality.com/Blog/bid/235096-Essential-Elements-of-a-Construction-Quality-QA-QC-Plan-Framework#:text=An%20executive%20overview%20G%20your%20QA%20company%20does%20to%20manage%20quality&text=The%20HOW%20details%20should%20be%20included%20in%20your%20policies%20and%20procedures%20document
  10. EN ISO 9001: 2000 “Quality Management Systems – Requirements”, published December 2000
  11. Ezzelle, J., Rodriguez-Chavez, I. R., Darden, J. M., Stirewalt, M., Kunwar, N., Hitchcock, R., & D’souza M. P. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. Journal of pharmaceutical and biomedical analysis, 2008; 46(1): 18-29.
  12. Bakshi, M., & Singh, S. Development of validated stability-indicating assay methods critical review. Journal of pharmaceutical and biomedical analysis, 2002; 28(6): 1011- 1040
  13.  How to set up QA Processes from Scratch https://www.browserstack.com/guide/setup-qa-process.
  14. Cockburn, I. M. The changing structure of the pharmaceutical industry. Health Affairs,       2004; 23(1): 10-22
  15. Carpenter, D. P. The political economy of FDA drug review: processing, politics, and lessons for policy. Health Affairs, 2004; 23(1): 52-63
  16. Kayser, O., & Warzecha, H. Pharmaceutical biotechnology: drug discovery and clinical applications. John Wiley & Sons 2012.
  17. Lund, W. The pharmaceutical codex: principles and practice of pharmaceutics (No. Ed. 12). Royal Pharmaceutical Society of Great Britain 1994.
  18. Henderson, R., Orsenigo, L., & Pisano, G. P. The pharmaceutical industry and the revolution in molecular biology: interactions among scientific, institutional, and organizational change. Sources of industrial leadership: studies of seven industries, 1999; 267-311

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Volume 12
[if 424 equals=”Regular Issue”]Issue[/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] 03
Received 27/06/2025
Accepted 31/07/2025
Published 11/10/2025
Retracted
Publication Time 106 Days

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