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Pharmaceutical process validation: An overview

Journal Article


Abstract


  • Drugs are critical elements in health care. They must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is also a regulatory requirement. This paper presents an introduction and general overview of this process, with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).

Publication Date


  • 2003

Citation


  • Aleem, H., Zhao, Y., Lord, S., McCarthy, T., & Sharratt, P. (2003). Pharmaceutical process validation: An overview. Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering, 217(2), 141-151. doi:10.1243/095440803766612801

Scopus Eid


  • 2-s2.0-0042311329

Start Page


  • 141

End Page


  • 151

Volume


  • 217

Issue


  • 2

Abstract


  • Drugs are critical elements in health care. They must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is also a regulatory requirement. This paper presents an introduction and general overview of this process, with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).

Publication Date


  • 2003

Citation


  • Aleem, H., Zhao, Y., Lord, S., McCarthy, T., & Sharratt, P. (2003). Pharmaceutical process validation: An overview. Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering, 217(2), 141-151. doi:10.1243/095440803766612801

Scopus Eid


  • 2-s2.0-0042311329

Start Page


  • 141

End Page


  • 151

Volume


  • 217

Issue


  • 2