Inhaltsangabe
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.
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Reseña del editor
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.
Biografía del autor
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.
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Suchergebnisse für Validation of Pharmaceutical Dosage Form: A Review
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Validation of Pharmaceutical Dosage Form
Verlag:
LAP LAMBERT Academic Publishing Okt 2013, 2013
ISBN 10: 3659478563
ISBN 13: 9783659478567
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Taschenbuch. Zustand: Neu. Neuware -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.Books on Demand GmbH, Überseering 33, 22297 Hamburg 80 pp. Englisch. Artikel-Nr. 9783659478567
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Validation of Pharmaceutical Dosage Form | A Review
Verlag:
LAP LAMBERT Academic Publishing, 2013
ISBN 10: 3659478563
ISBN 13: 9783659478567
Neu
Taschenbuch
Anbieter: preigu, Osnabrück, Deutschland
Verkäuferbewertung 5 von 5 Sternen
Taschenbuch. Zustand: Neu. Validation of Pharmaceutical Dosage Form | A Review | Kamal Singh Rathore (u. a.) | Taschenbuch | 80 S. | Englisch | 2013 | LAP LAMBERT Academic Publishing | EAN 9783659478567 | Verantwortliche Person für die EU: BoD - Books on Demand, In de Tarpen 42, 22848 Norderstedt, info[at]bod[dot]de | Anbieter: preigu. Artikel-Nr. 105606193
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