C. Girani
C. Girani is regulatory affairs specialist at Laboratorio Farmaceutico SIT, Via Cavour, 70, 27035 Mede, Italy.
Articles
Process Validation of Legacy Product
April 2nd 2015The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.
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Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification
