Computerized Systems Validation (CSV) in Biopharmaceutical Industries

Authors: Hesham A* and Patan IK

DOI: 10.23880/oajpr-16000219

Volume 4, Issue 4

Abstract

The biopharmaceutical industries has more and more used computers to support and accelrate producing of their products. Computer systems also are accustomed support routine offer of high quality products to boost production process performance, scale back production prices, and improve product quality. it's vital that these systems square measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems used to manage data or support descion making subject to review by regulated authorities whether they are being submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks, Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems validation for biopharmaceutical indsutries are highlighted.

Keywords: Computer system validation; CSV, GAMP;, Validation; Qualification; Biopharmaceuticals; GMP

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