A Review on Process Validation

  • Surya Pratap Singh Kota College of Pharmacy
  • Kailash Dhaker Kota College of Pharmacy
  • Abhisek Namdev Kota College of Pharmacy
  • Mahaveer Prasad Khinchi Kota College of Pharmacy
  • Surbhi Bhatnagar Kota College of Pharmacy
Keywords: Process Validation, Statistical tools, Quality, Productivity, Assurance, Analytical

Abstract

Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Basically, Process validation emphasize the role of objective measure and statistical tools and analyses knowledge, detection, and control of variability and give assurance on consistent of quality / productive throughout life cycle of product. Result from Process validation method can be used to judge the quality and consistency of analytical result. The purpose of this review to cover need of process validation, principle of process validation, type of process validation, phase of process validation, strategy for process validation. In this review article we discussed about the importance and strategy of validation of analytical procedure.

Author Biographies

Surya Pratap Singh, Kota College of Pharmacy

Department of pharmaceutics,
Kota College of  Pharmacy,
Kota, Rajasthan, India

Kailash Dhaker, Kota College of Pharmacy

Department of pharmaceutics,
Kota College of  Pharmacy,
Kota, Rajasthan, India

Abhisek Namdev, Kota College of Pharmacy

Department of pharmaceutics,
Kota College of  Pharmacy,
Kota, Rajasthan, India

Mahaveer Prasad Khinchi, Kota College of Pharmacy

Department of pharmaceutics,
Kota College of  Pharmacy,
Kota, Rajasthan, India

Surbhi Bhatnagar, Kota College of Pharmacy

Department of pharmaceutics,
Kota College of  Pharmacy,
Kota, Rajasthan, India

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Published
2016-12-01
How to Cite
[1]
Singh, S.P., Dhaker, K., Namdev, A., Khinchi, M.P. and Bhatnagar, S. 2016. A Review on Process Validation. PharmaTutor. 4, 12 (Dec. 2016), 9-19.