Articles liés à Validation of Pharmaceutical Dosage Form: A Review

Validation of Pharmaceutical Dosage Form: A Review - Couverture souple

Rathore, Kamal Singh; Sher, Kavita; Pujara, Naisarg

 
9783659478567: Validation of Pharmaceutical Dosage Form: A Review
Couverture souple
ISBN 10 : 3659478563 ISBN 13 : 9783659478567
Editeur : LAP LAMBERT Academic Publishing, 2013

Synopsis

Quality, safety and effectiveness must be built into the product. This requires careful attention to a number of factors such as the selection of quality materials/components, product and process design, control of processes, in-process control, and end-product testing. Due to the complexity of the drug products, routine end-product testing alone is not sufficient due to several reasons. Furthermore, quality cannot be tested into the finished drug product but rather be built in the manufacturing processes and these processes should be controlled in order that the finished product meets all quality specifications. A careful design and validation of systems and process controls can establish a high degree of confidence that all lots or batches produced will meet their intended specifications.The Validation Master Plan should be a summary document and should therefore be brief, concise and clear. It should not repeat information documented elsewhere but should refer to existing documents such as policy documents, SOP's and validation protocols and reports. The validation master plan should provide an overview of entire validation operation, its organizational structure & its content.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

Quality, safety and effectiveness must be built into the product. This requires careful attention to a number of factors such as the selection of quality materials/components, product and process design, control of processes, in-process control, and end-product testing. Due to the complexity of the drug products, routine end-product testing alone is not sufficient due to several reasons. Furthermore, quality cannot be tested into the finished drug product but rather be built in the manufacturing processes and these processes should be controlled in order that the finished product meets all quality specifications. A careful design and validation of systems and process controls can establish a high degree of confidence that all lots or batches produced will meet their intended specifications.The Validation Master Plan should be a summary document and should therefore be brief, concise and clear. It should not repeat information documented elsewhere but should refer to existing documents such as policy documents, SOP's and validation protocols and reports. The validation master plan should provide an overview of entire validation operation, its organizational structure & its content.

Biographie de l'auteur

Dr.Kamal Singh Rathore is Associate Professor and Head of Department of Pharmaceutics at B N Institute of Pharmaceutical Sciences, Udaipur, INDIA. He is engaged in research, academic and Pharma professional activities from last 20 years. He has authored more than 80 national and international scientific articles and papers presentations.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2013
Langue
anglais
ISBN 10 
3659478563
ISBN 13 
9783659478567
Reliure
Broché
Nombre de pages
80
Coordonnées du fabricant
non disponible
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