Pharmaceutical Process Validation: A Mini Review


  • Tenzin Wangpo Sun Rise University, Alwar, Rajasthan, India.
  • D. S. Rathore Professor, Department of Pharmacy,Goenka College of Pharmacy, Bikaner road, Laxmangarh, Rajasthan, India.
  • Yogendra Singh Dean Pharmacy, Sun Rise University, Alwar, Rajasthan, India.


Master plan, Quality Assurance, Pharmaceutical Validation, Pharmaceutical Process Control.


Pharmaceutical Process Validation emphasizes on process design elements and maintaining process control during commercialization and communicate that process validation is an ongoing program and align process validation activities with product lifecycle. According to GMP validation studies are essential part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. The validation study provide the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality assurance.

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How to Cite

Wangpo, T., Rathore, D. S., & Singh, Y. (2018). Pharmaceutical Process Validation: A Mini Review. International Journal of Health and Biological Sciences, 2(2), 09–12. Retrieved from