Process analytical technology (PAT) tools: Uses in pharmaceutical manufacturing

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

Abstract

Process analytical technologies (PAT) have been mostly applied for designing, analyzing and controlling various processes functional during product manufacturing. These technologies are utilized for providing necessary informations about various parameters that could significantly affect different critical quality attributes (CQA). PAT is efficiently used to examine the raw material and final product quality, both physically and chemically, leading to reduction in engineering costs and thus improves the manufacturing sector of the pharmaceutical or chemical industries. PAT have provided effective tools which have improved the operative control and amenability, so resulted in continuous and instantaneous quality improvement of products. PAT includes a transferal from analyzing the quality of product development to the quality of final products by examining at various intermediate (in- or out-line processing)stages. As considered for industrial sector, this technique has emerged as a novel tool and numerous work is going on at academic and industrial level. Herein, we have explored the various aspects of PAT, including significant role of QbD (Quality-by-Design), in various industrial processes and manufacturing aspects.

Original languageEnglish
Title of host publicationAdvances and Challenges in Pharmaceutical Technology
Subtitle of host publicationMaterials, Process Development and Drug Delivery Strategies
PublisherElsevier
Pages243-259
Number of pages17
ISBN (Electronic)9780128200438
DOIs
Publication statusPublished - 1 Jan 2021
Externally publishedYes

Keywords

  • Analytical tools
  • FDA
  • Industrial processes
  • PAT
  • QbD

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