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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
C. Girani is regulatory affairs specialist at Laboratorio Farmaceutico SIT, Via Cavour, 70, 27035 Mede, Italy.
April 02, 2015
The 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.