Author(s):
Prachi Rajesh Patil, Sunila A Patil, Shweta Vinod Raul
Email(s):
prachirpati12323@gmail.com
DOI:
10.52711/2349-2988.2025.00044 
Address:
Prachi Rajesh Patil, Sunila A Patil, Shweta Vinod Raul
Department of Pharmacognosy, Pravara Rural College of Pharmacy, Pravaranagar, Maharashtra, India, 413736.
*Corresponding Author
Published In:
Volume - 17,
Issue - 4,
Year - 2025
ABSTRACT:
The international methods for determining the amount of geotaxis impurities (residual solvents and different inorganic and organic impurities) in pharmaceuticals are presented in this succinct review. Due to national and international requirements, it is now required to disclose both the purity and impurity profiles of a given pharmaceutical product. These factors, as well as the importance of pharmaceutical quality, efficacy, and safety, are covered, along with the types of impurities, their sources, their control, and regulatory considerations. One of the requirements for the provision of any nation's healthcare system is the availability of high-quality critical medications, since subpar medications have the potential to cause harm or even death to users. Even in very minute amounts, the presence of undesirable compounds in a given medication may affect both its safety and effectiveness. A pharmaceutical is a dynamic product, unlike those in other sectors, and its color, consistency, weight, and even chemical identity can vary between production and final consumption. 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. Impurities in pharmaceutical and drug products are undesirable substances (organic, inorganic, and residual solvents) that are either added or developed during formulation, age, or remain 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.
Cite this article:
Prachi Rajesh Patil, Sunila A Patil, Shweta Vinod Raul. Quality Control and Quality Assurance in Pharmaceutical Industry. Research Journal of Science and Technology. 2025; 17(4):319-4. doi: 10.52711/2349-2988.2025.00044
Cite(Electronic):
Prachi Rajesh Patil, Sunila A Patil, Shweta Vinod Raul. Quality Control and Quality Assurance in Pharmaceutical Industry. Research Journal of Science and Technology. 2025; 17(4):319-4. doi: 10.52711/2349-2988.2025.00044 Available on: https://rjstonline.com/AbstractView.aspx?PID=2025-17-4-8
REFERENCES:
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. 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