FDA Qualification for Equipment and Utilities of Revlon production site in Pla de Santa Maria

Identifier:  TFM:1237

Handle: https://hdl.handle.net/20.500.11797/TFM1237

Authors:  Sanromà Ortiz, Christian-Aleix

Abstract:
Revlon decided to engage in an organizational strategy of selling certain specific products to the United States, bringing some of these products to the production center in Spain. This resulted in adapting certain parts of the production center to meet FDA requirements and having to qualify a certain amount of equipment and utilities. The qualification is based on risk analysis, IQ, OQ and PQ protocols depending on the equipment or utility. For new equipment, the URS, DQ, FAT, SAT, IQ, OQ and PQ are performed. A study was also carried out to improve the cleaning of the reactors.