Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification

Patel, Mitesh; Patel, Kanu; Patel, Mukesh

ISBN 10: 3659405086 / ISBN 13: 9783659405082

Editore: LAP LAMBERT Academic Publishing, 2013

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Codice articolo I-9783659405082

Dati bibliografici

• Titolo: Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
• Editore: LAP LAMBERT Academic Publishing
• Data di pubblicazione: 2013
• Lingua: Inglese
• ISBN 10: 3659405086
• ISBN 13: 9783659405082
• Rilegatura: Brossura
• Condizione: New

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Riassunto

Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteria's were considered.

Informazioni sull?autore

I had done my b.pharma from east wast college of pharmacy, Bangalore and I done my m.pharma from shri b m shah college of pharmaceutical and research, modasa. I also attended 3 national seminar related to pharmacy profession and published 2 review article and 1 research article.