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A Review on Process Validation

Journal: International Journal of PharmaO2 (IJPO) (Vol.2, No. 6)

Publication Date:

Authors : ; ;

Page : 0368-0376

Keywords : Validation; Process Validation; Protocol; Documents.;

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Abstract

Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated, we can assure that the final product is of the best quality. Process validation is the process for improving the safety and quality of the dosage from which is manufactured in the pharmaceutical industry. Basically process validation emphasize the role of objective measure and statistical tools and control of validation 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 validation study provides 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.

Last modified: 2020-11-27 17:31:29