Process Validation Vs Process Qualification -
An Overview

Preeti kulkarni; Anil Ghule; Sandip Badadhe

doi:https://doi.org/10.14445/22315381/IJETT-V67I7P201

Research Article | Open Access | Download PDF

Volume 67 | Issue 7 | Year 2019 | Article Id. IJETT-V67I7P201 | DOI : https://doi.org/10.14445/22315381/IJETT-V67I7P201

Process Validation Vs Process Qualification - An Overview

Preeti kulkarni, Anil Ghule , Sandip Badadhe

Citation :

Preeti kulkarni, Anil Ghule , Sandip Badadhe, "Process Validation Vs Process Qualification - An Overview," International Journal of Engineering Trends and Technology (IJETT), vol. 67, no. 7, pp. 1-4, 2019. Crossref, https://doi.org/10.14445/22315381/IJETT-V67I7P201

Abstract

Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Validation studies are conducted in accordance with pre-defined protocols. Written reports summarizing recorded results and conclusions are prepared, evaluated, approved and maintained. Validation is the mean of catering enormous benefits to even more than the acceptable quality level which in the global standard scale. Lending importance to validation is increasingly profound in recent years. Validation is the art of designing and practicing the designed steps alongside with the documentation.

Keywords

Validation, Qualification, Process, Quality.

References

[1] "Process Qualification". Atris Information Systems. Retrieved November 17, 2014. "Guidance for Industry Process Validation: General Principles and Practices" (PDF). Food and Drug Administration. Retrieved November 17, 2014.
[2] U.S. Department of Health and Human Services Food and Drug Administration, January 2011, Current Good Manufacturing Practices (CGMP) Revision 1.
[3] WHO Expert Committee on Specifications for Pharmaceutical Preparations Who Technical report series 992, 49th report.
[4] WHO Expert Committee on Specifications for Pharmaceutical Preparations Who Technical report series 937, 40th report.
[5] "Process Validation A Lifecycle Approach" (PDF). Food and Drug Administration. Retrieved November 17, 2014.
[6] "PROCESS QUALIFICATION (P2Q)". Validation-online.net. Retrieved November 17, 2014.