A REVIEW ON PHARMACEUTICAL PROCESS VALIDATION OF SOLID DOSAGE FORM [TABLETS]

  • Rishi Ram Parajuli
  • Saroj Shrestha TIME Pharmaceuticals Pvt. Ltd, Nepal
  • Shreekrishna Lamichane TIME Pharmaceuticals Pvt. Ltd, Nepal
  • Priyanka Pokhrel TIME Pharmaceuticals Pvt. Ltd, Nepal

Abstract

The article gives an introduction and general overview on process validation of pharmaceutical tablet manufacturing process. Process Validation is one of the important steps in achieving and maintaining the quality of final product. Process validation emphasizes the role of statistical tools and analyses, knowledge, detection, and control of variability and thus gives assurance on consistency of quality product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the established and documented test methods employed by the manufacturer. Thus, validation is an essential part of the quality assurance. This review examines the need for pharmaceutical validation, the various approaches, process and steps to be monitored during tablet manufacturing process.

Key words: Process Validation, Types, Validation Stages, Guidelines and Process.

 

Keywords: Prodrugs, Drug Delivery, Classification, Evaluation

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Author Biographies

Rishi Ram Parajuli
Production Pharmacist
Saroj Shrestha, TIME Pharmaceuticals Pvt. Ltd, Nepal

TIME Pharmaceuticals Pvt. Ltd, Nepal

Shreekrishna Lamichane, TIME Pharmaceuticals Pvt. Ltd, Nepal

TIME Pharmaceuticals Pvt. Ltd, Nepal

Priyanka Pokhrel, TIME Pharmaceuticals Pvt. Ltd, Nepal

TIME Pharmaceuticals Pvt. Ltd, Nepal

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How to Cite
1.
Parajuli R, Shrestha S, Lamichane S, Pokhrel P. A REVIEW ON PHARMACEUTICAL PROCESS VALIDATION OF SOLID DOSAGE FORM [TABLETS]. JDDT [Internet]. 15Nov.2015 [cited 30Mar.2020];5(6):1-. Available from: http://jddtonline.info/index.php/jddt/article/view/1109