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toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage.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'. N� de ref. del art�culo 9786138502579

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T�tulo: Impurity profiles of API - Challenges for ...

Editorial: Scholars' Press

A�o de publicaci�n: 2018

Encuadernaci�n: Taschenbuch

Condici�n: Neu

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Sinopsis:

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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Das Unternehmen AHA-BUCH GmbH: Seit der Gr�ndung von AHA-BUCH im Juli 2005 ist unser Hauptziel, zufriedenen Kunden so schnell und so preisg�nstig wie m�glich ihren B�cherwunsch zu erf�llen. Unsere Firma besch�ftigt 16 Mitarbeiter, die nur ein Ziel kennen: den Kunden und seine W�nsche! Auf �ber 3700 m2 Fl�che haben wir �ber 100.000 B�cher, Modernes Antiquariat und Spiele auf Lager.

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