Impurity Profiles Api Challenges by Chakravarthy (8 results)

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toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage.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.

Condition: New. pp. 144.

Paperback. Condition: Brand New. 144 pages. 8.66x5.91x0.33 inches. In Stock.

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.

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.

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'.

Condition: New. Print on Demand pp. 144.

Condition: New. PRINT ON DEMAND pp. 144.