Bookcover of Impurity profiles of API - Challenges for cGMP Inspections in MSME
Booktitle:

Impurity profiles of API - Challenges for cGMP Inspections in MSME

GMP audits and API impurity profiles

Scholars' Press (2018-12-26 )

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ISBN-13:

978-613-8-50257-9

ISBN-10:
6138502574
EAN:
9786138502579
Book language:
English
Blurb/Shorttext:
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toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage.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"
Publishing house:
Scholars' Press
Website:
http://www.scholars-press.com
By (author) :
Dr. B. K. Chakravarthy
Number of pages:
144
Published on:
2018-12-26
Stock:
Available
Category:
Pharmacy
Price:
67.90 €
Keywords:
cGMP Audits, API, Impurity profiles

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