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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification - Couverture souple
Synopsis
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.
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À propos de l?auteur
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.
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
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LAP LAMBERT Academic Publishing, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
Neuf
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Edité par
LAP LAMBERT Academic Publishing, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
Neuf
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Process Validation, Area and Equipment Qualification Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Edité par
LAP LAMBERT Academic Publishing, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
Neuf
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Edité par
LAP LAMBERT Academic Publishing, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
Neuf
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Process Validation, Area and Equipment Qualification Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
Edité par
LAP LAMBERT Academic Publishing, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
Neuf
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
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LAP LAMBERT Academic Publishing, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
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Process Validation, Area and Equipment Qualification: Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification
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Process Validation, Area and Equipment Qualification
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LAP LAMBERT Academic Publishing Jun 2013, 2013
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Taschenbuch. Etat : Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 96 pp. Englisch. N° de réf. du vendeur 9783659405082
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Process Validation, Area and Equipment Qualification
Edité par
LAP LAMBERT Academic Publishing, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
Neuf
Couverture souple
Vendeur : moluna, Greven, Allemagne
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Etat : New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Patel MiteshI 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 profess. N° de réf. du vendeur 5154119
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Process Validation, Area and Equipment Qualification
Edité par
LAP LAMBERT Academic Publishing Jun 2013, 2013
ISBN 10 : 3659405086
ISBN 13 : 9783659405082
Neuf
Taschenbuch
Vendeur : buchversandmimpf2000, Emtmannsberg, BAYE, Allemagne
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Taschenbuch. Etat : Neu. This item is printed on demand - Print on Demand Titel. Neuware -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 criteriäs were considered.Books on Demand GmbH, Überseering 33, 22297 Hamburg 96 pp. Englisch. N° de réf. du vendeur 9783659405082
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