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Impurity profiles of API - Challenges for cGMP Inspections in MSME: GMP audits and API impurity profiles - Softcover
Synopsis
API’s are being manufactured all over the globe at varied conditions keeping updated cGMP regulations. However, due to business constrains many API manufacturers especially micro, small and medium scale entrepreneurs (MSME) do tend to neglect systematic continuous recording and documentation process as per cGMP guidelines and have to pay heavy price when cGMP audits take place. API manufacturers do constant innovative research to minimise cost and time to be globally competitive. New innovations can lead to development of some unknown impurities, may be within of quantitative limits but unknown qualitative factors and if care is not taken for such molecules being identified and not controlled before release for open market with proper technology transfers,it is likely that newer impurities can be developed and contribute to unreported clinical toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage. GMP inspector cannot verify each and every batch manufactured for any deviations, but sure to appreciate if followed a dictum “do what is written in SOP and write what has been done"
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- PublisherScholars' Press
- Publication date2018
- ISBN 10 6138502574
- ISBN 13 9786138502579
- BindingPaperback
- LanguageEnglish
- Number of pages144
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Impurity profiles of API - Challenges for cGMP Inspections in MSME
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Scholars' Press Dez 2018, 2018
ISBN 10: 6138502574
ISBN 13: 9786138502579
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Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany
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Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -API's are being manufactured all over the globe at varied conditions keeping updated cGMP regulations. However, due to business constrains many API manufacturers especially micro, small and medium scale entrepreneurs (MSME) do tend to neglect systematic continuous recording and documentation process as per cGMP guidelines and have to pay heavy price when cGMP audits take place. API manufacturers do constant innovative research to minimise cost and time to be globally competitive. New innovations can lead to development of some unknown impurities, may be within of quantitative limits but unknown qualitative factors and if care is not taken for such molecules being identified and not controlled before release for open market with proper technology transfers,it is likely that newer impurities can be developed and contribute to unreported clinical toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage. GMP inspector cannot verify each and every batch manufactured for any deviations, but sure to appreciate if followed a dictum 'do what is written in SOP and write what has been done' 144 pp. Englisch. Seller Inventory # 9786138502579
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Impurity profiles of API - Challenges for cGMP Inspections in MSME
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Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Chakravarthy Dr. B. K.Dr. B. K.Chakravarthy: Experience with nearly 80 research communications in Pharma Research, Manufacturing marketing, GMP validations and Audits, I P S. Best Published paper. Gold medal, Working group member Ind. Seller Inventory # 385852892
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Impurity profiles of API - Challenges for cGMP Inspections in MSME : GMP audits and API impurity profiles
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Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - API's are being manufactured all over the globe at varied conditions keeping updated cGMP regulations. However, due to business constrains many API manufacturers especially micro, small and medium scale entrepreneurs (MSME) do tend to neglect systematic continuous recording and documentation process as per cGMP guidelines and have to pay heavy price when cGMP audits take place. API manufacturers do constant innovative research to minimise cost and time to be globally competitive. New innovations can lead to development of some unknown impurities, may be within of quantitative limits but unknown qualitative factors and if care is not taken for such molecules being identified and not controlled before release for open market with proper technology transfers,it is likely that newer impurities can be developed and contribute to unreported clinical toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage. GMP inspector cannot verify each and every batch manufactured for any deviations, but sure to appreciate if followed a dictum 'do what is written in SOP and write what has been done'. Seller Inventory # 9786138502579
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Impurity profiles of API - Challenges for cGMP Inspections in MSME
Published by
Scholars' Press Dez 2018, 2018
ISBN 10: 6138502574
ISBN 13: 9786138502579
New
Taschenbuch
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germany
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Taschenbuch. Condition: Neu. Neuware -API¿s are being manufactured all over the globe at varied conditions keeping updated cGMP regulations. However, due to business constrains many API manufacturers especially micro, small and medium scale entrepreneurs (MSME) do tend to neglect systematic continuous recording and documentation process as per cGMP guidelines and have to pay heavy price when cGMP audits take place. API manufacturers do constant innovative research to minimise cost and time to be globally competitive. New innovations can lead to development of some unknown impurities, may be within of quantitative limits but unknown qualitative factors and if care is not taken for such molecules being identified and not controlled before release for open market with proper technology transfers,it is likely that newer impurities can be developed and contribute to unreported clinical toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage. GMP inspector cannot verify each and every batch manufactured for any deviations, but sure to appreciate if followed a dictum ¿do what is written in SOP and write what has been done'VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 144 pp. Englisch. Seller Inventory # 9786138502579
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Impurity profiles of API - Challenges for cGMP Inspections in MSME: GMP audits and API impurity profiles
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Paperback. Condition: Brand New. 144 pages. 8.66x5.91x0.33 inches. In Stock. Seller Inventory # zk6138502574
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